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Food and Drug Administration Advisory Committee

peripheral & Central Nervous System VOL 1, April 28, 1$)$)8

1,64970:25; 71:1 1990125:11,


12; 249:25 3,29962:10 5,0002126:10
$ 1,750107:25 1991190:2 3,300143:5, 6; 152:13,14 5,002125:24
1.3216:22 199451:13 3,40012:25 5,05012:25
.-
--< $20,00049:19 1995249:25 3,40670:21,22 50 11:22; 26:6,19,23, 25;
1.5185:6
$4049:14 1.635:9 1998 43:17; 205:23 3,994 124:1; 190:2,18 35:15, 21; 37:15, 23; 38:2,
$40,00049:18 199942:13 15,19; 39:16 ;40:4; 41:3,
1.7214:15 3-standard 130:13
1:00178:4 12; 42:7,15, 18; 44:2;
$60,00049:15 1021:16, 16;33:4,8; 3.1217:22
50:15; 56:2,3,5, 7; 57:11;
43:4; 44:9,13,16,22, 25; 3.2216:13 58:21; 59:4, 8; 71:8, 14;
0 48: 15; 50:3; 52:9; 79:1;
126:8; 151:24; 157:8;
2 3.7216:11 82:9; 93:17; 94:8; 95:7;
166:10; 172:8, 8; 199:22;
30 24:21,24,25; 26:19;
172:22; 173:13; 201:14;
2 12:14; 95:23, 23; 149:3, 35:15; 39:18; 54:21, 23; 204:12, 16; 209:8, 9;
0.00002158:18 217:15; 238:2; 241:13;
259:20, 22; 265:1,17
3; 158:17; 177:24; 1!M23; 56:10,13, 20; 57:3; 70:24;
0.001 119:13; 125:2; 248:22; 259:2; 271 :17;
214:12; 266:10; 267:8, 16; 134:14,17. ‘V; 149:16; 50,000 228:5; 238:10
126:4,5; 129:11, 12; 292:22
269:9, 10; 277:23; 278:6; 152:5, 7; 170:14; 172:21; 50-5045:3
130:8; 132:8; 152:15, 18; 1O-minute 79:1 173:12; 186:6; 192:20;
280: 16; 281:4,10,12, 14; 540,000197:15
153:8,9 1O-yaar 106:14 282:5 238:1 ;241:13;245:14
0.00125 242:21; 244:4 10.3158:13 5897:2
2,000253:14 30-mg 34:8
0.002119:15, 126:7; 10.6190:3 59 14:20; 96:3; 152:5,7;
2,58470:23 30034 :11,25; 35:3;
153:4; 208:3; 215:21 160:19; 192:19
100 34:22; 53:24; 93:17; 2.6 35:10; 217:17 36:10; 39:8; 53:24; 54:14, —
0.003 158:7; 244:4 194:13; 256:25 18,19,21,23, 24; 56:10,
2.7217:2,3
0.006119:14 100,000 158:17; 173:9; 20 14:5; 48:15 ;60:13; 13;68:2,17;245:15 6
0.008 126:8; 153:4; 242:1 84:2; 107:1Q 233:14; 300-mg 34:9
208:4; 215:22; 284:14 102213:13 238:1,2 ;241:13;257:1 307213:21 6126:8
0.05147:1, 6; 219:4 10746:13,14 20,000238:8,23 32370:11 6,00061:9,10, 13;
0.05-squared 243:13 108 151:14; 213:15 200 13:25; 26:2; 83:9; 325 11:22; 38:12, 13,21; 206:24; 238:7
0.079 158:13; 217:11; 11 156:17; 157:4; 185:4 171:18, 19; 204:11 39:22; 40:3; 41:3; 42:4,12, 6,43162:6
218:5,7 1291:15; 124:1 ;158:11; 206213:20 13; 55:13; 57:25; 58:6, 21; 6,602209:25
0.084 158:12; 217:18; 190:16; 217:21 2087:2 59:4, 8; 63:21; 94:7; 6.255:17
218:10 12.2158:7 208(b)(3 6:9 204:17
60 30:12; 209:24
0.1579218:6 120 70:8; 91:6 20g 250:3 33 12:24; 233:13; 238:19
60014:18
.
.~ 0.167218:11 12A30 6:13 21 63:8; 156:2; 181:25 330208:12
62155:22
0.2 216:20; 217:5,5 13 11:25; 14:20; 52:11, 21.2152:16 34155:21
64213:12
0.2586:4, 19; 243:3 25; 53:7, 14; 54:3, 6; 96:2; 22 51:23; 52:6; 63:12; 35107:13
65195:15
151:25; 156:18; 209:24 153:3 37 71:3; 153:7; 189:15
0.27219:3 65055:14
13,000127:22 2363:8;71:1; 156:3; 3935:3
0.3243:3 6946:10,14
138248:13 216:6
0.586:20
0.51218:25
14 54:3; 91:12; 158:6;
189:14
24 21:2; 35:1; 42:5;
136:17; 140:20; 151:2;
4 7
0.74216:23
14051:15 153:3; 159:3; 188:10, 14;
0.79216:17 190:16 ;208:13;217:16 4 49:7; 71:2; 82:23; 83:25;
14346:7 7 63:11; 185:13; 265:21;
0.8586:25 190:23; 195:7; 242:2
14452:16 24.4158:16 269:19; 281:7,13,15, 20;
001 106:10; 237:13 4,000 122:16; 127:20; 282:15,22, 25; 283:3,8,
148155:19 24.7216:5
002158:8 130:11 12; 290:24
15 44:9; 47:10, 23; 2526:2,5, 11; 91:8;
01242:7 4,190190:18 7,000 43:8; 107:24;
151:18; 172:22; 173:13; 107:16; 185:6,6; 204:11;
05 105:17; 242:21 238:18 4.935:10 108:11; 124:12; 206:22
238:8, 23; 241:13; 280:11
25-mg 13:23 40 155:20; 172:21; 7,040209:23
15,000117:1
173:12 ;238:10
1 150,00049:4 26 21:4; 152:6; 189:15;
192:21 40,000 26:24; 40:4
7050:14,15
70013:24
16 52:12; 152:2
266213:21 400 68:17; 83:7; 204:12
160,000 195:6; 197:14 700,0001 1:4; 197:13;
1 12:10; 18:8; 60:3; 84:1; 44151 :15; 241:25
26th 150:21 201:12
99:14; 153:9, 9; 173:9; 162.538:11
27 51:22; 52:25 44391:7 730,000 49:1; 195:4
177:19; 180:16; 190:7, 23; 165213:15
210:11 ;213:1;242:1; 271213:21 45195:6 7539:6, 11; 56:4,9;
17 52:6; 53:9, 14; 91:2,8;
252:12, 22; 266:9; 267:8, 28 IG1:17 208: 12; 209:9
185:5
16; 268:4; 269:6; 270:8;
277:23; 278:12; 281:4,7
17646:6,10 284-patient 68:18 5 75746:5
78214:1
179248:12 2g 35:2
1,000 34:11; 35:3; 54:24; 79.9217:21
186:9;7:2; 11:25; 52:2; 2:00 178:5; 179:2 5 33:4,8; 43:4; 44:9,13,
99:15; 106:25; 118:24;
152:4; 156:16, 17; 190:7; 70:24 25; 56:22; 57:2; 70:3, 24;
,=+ 192:19,20,21 19 152:14; 182:1 3 81:15; 82:18; 83:20;
185:13, 25; 238:7; 242:2
?3
1,200 34:25; 36:11 19,000117:1
5,00097: 12; 120: 18;
1,25097:12 198043:17 3 216:14; 220:15; 228:24; 8 63:4,6; 106:14; 201:14;
122:6,8,14,17,19, 22;
1,30055:14 1980s 43:1o 281:7,13,15, 20; 282:17; 214:13
123:8,12, 23; 124:12;
1,50055:11 1984194:17 283:3; 292:24 127: 18; 129:20; 228:4; 8,000 118:23; 265:21
1;600122:11 198884:9 3,00056:17:62:8:122: 12 233:2:253:14 8.455:18

Miller Reporting Company, Inc. Min-u-seripml (1) $20,000 -8.4


Advisory Committee Food and Drug Administration
“VOL1, April 28, 1998 Peripheral & Central Nervous System

8027:16, 18; 82:23; accepting 132:10 202:12; 224:14,20,21, 22; 125:19; 220:8 162:9; 182:5; 184:13;
86:20; 87:1; 113:3; 189:7; accidents 141:15 242:22; 264:10 administer- 166: 10; 185:12, 23; 186:17;
256:21,25 accordance 6:9 added 18:16; 74:10, 22; 196:16 193:12; 207:22; 208:1;
=A217:13 111:7; 148:12; 154:24; administered 83: 12; 209:14, 14;217:17, 19; ~
account 50:22; 167:8;
~ a 34:24 170:24; 221:9; 224:12; 87:4; 95:12 218:1 1; 219:3; 243:12;
190:20; 229:16; 242:25;
244:9; 245:14, 15; 253:7; 270:12; 279:25; 284:25;
81 55:13; 58:5 261:17 ;290:1 Administration 203:5
275:13 289:14, 22; 291:4
82.4217:13,21 ACCP 61:17; 65:17,20 administrative 162:3
adding 75:8; 116:23; against 12:12; 56:4, 5;
8547:13 accumulate 122:8, 10; 166:4; 239:24 admit 74:10; 162:2 59:15, 20; 60:24; 75:18;
86.7 215:25; 216:10, 10 172:24 admittedly 102:14 148:12; 187:23; 233:12;
addition 15:20; 16:2;
87.1216:3 accumulated 122:6 26:22; 36:9; 87:5; 90:20; adopt 120:14 269:24; 271:4; 284:9
88.5216:20 accumulating 86:ll 94:5; 97:13; 120:21; ADP 85:19, 22; 86:10 age %:8; 182:22; 188: 16;
88.7 216:20; 217:1 accurately 235:7; 133:7; 139:5; 200:14; adult 97:2; 197:17 195:15; 199:22; 210:3
274:23; 289:15 253:13 agency 5:7; 7:3; 196:21;
88.9217:1 adults 200:16
accused 290:8 additional 15:1; 17:1; 272:10
89.9 215:25; 216:2,10 advance 9:9; 191 :23;
76:14; 107:1; 116:24; 220:6; 239:23; 258:15 agency’s 6:13; 7:6
ACE 55:1o
120:21; 140:13; 189:T
achieve 130:11; 239:18 advances 90:2 agenda 6:2; 7:11, 22;
9 achieved 15:1
202:7; 208:9, 10; 248:1;
263:25 advantage 81:17; 91:24; 191:14
achieving 131:4, 4; additive 14:14; 82: 13; 142:24; 146:6,9, 11; agent 11:14; 12:7; 31:4,
954:3, 14;63:11; 156:18; 95:11; 143:13; 144:1; 258:5,25 16; 33:2; 53:6; 60:17, 22;
239:22
214:11 152:19; 154:5; 157:19; advantageous 258:13 62:2; 65:22; 184:1; 281:16
acne 164:21
9.2157:2 158:20; 159:2; 160:23; advantages 59:13; 60:19 agents 11:9, 10; 13:19;
across 23:20; 26:19;
900 34:22; 53:25 192:2; 276:8; 290:18 adverse 14:9; 26: 13; 17:18 ;31:11; 32:5; 50:25;
96:3; 114:18; 126:11;
91108:2 additives 143:14 60:19; 66:9,12, 17; 101:2; 51:3,10,19, 25; 52:4;
142:5, 9; 145:8; 155:11;
additivity 155:18; 160:1; 114:21, 24; 115:9; 179:22; 53:8, 11; 59:11; 61:20, 24;
95 52:14; 53:22; 54:3 161:2; 169:12, 20; 180:20;
237:6 180:2, 15; 181:21; 183:15; 62:1; 63:15; 64:7,10, 13;
97 129:7; 150:21 186:4; 207:2, 3,3; 210:22;
184:16,19, 23; 186:13,16, 65:7,9, 11;66:10, 20;
219:9; 225:6; 241:1; address 7:16; 18:23;
22; 202:7; 214:3,4,6,7, 80:21, 24; 198:17; 202:5
246:25 19:5, 18; 36:5; 79:22, 24;
A act 158:1 95:6, 15; 117:24; 119:9,
21;263:19; 283:25; 284:1 ages 195:15
10; 148:16; 162:13; 194:1; advertise 292:2 aggregability 26:23
acted 108:3
252:5; 264:9; 277:8; advice 17:13; 23:2, 9; aggregate 80: 10; 88:11;
AB 146:21,21; 237:10, action 13:20; 41:8; 74:18;
~%- +5 288:25 113:16; 130:24; 193:14; 173:8
75:20; 76:5; 77: 13; 79:23,
addressed 5:11; 82:16; 260:23 aggregates 47:18
:y 23:5; 27:14; 25; 92:1,8
65: 10; 87:2; 109:20; advisers 29:8 aggregation 26: 10; 27:9,
142:24; 151:13; 198:17 activated 80: 10; 85:18,
111:17; 112:21 ;123:7 advising 281:21 20;85:15
able 9:18; 13:8; 29:20; 23; 86:9
addresses 5:23; 68: 13; Advisory 9: 12; 39:22; Aggrenox 6: 17; 7:9; 8:7;
56:17; 116:17; 151:17; activates 85:5
160:20; 172:1; 230:23; 143:10 1%:2, 10; 197:3, 4,5; 10:18, 25; 13:12,14,15,
activation 85:14; 86:7,
235:6, 23; 236:6; 239:2; addressing 43:3; 84:7 201:10; 252:2; 277:3 18; 14:3, 24; 15:5,17,21,
13; 93:21; 94:1
251:7; 262:16; 281:4, 15; adenosine 27:14, 17; advocate 76:20; 198:22 22; 16:2; 17:4,7, 20;
activator 85:2 21:10, 16;29:11; 37:14;
282:7; 286:19 85:16,24, 25; 86:3,5,10, AE 180:7; 181:17
active 13:19; 92:24; 97:8; 11;87:1, 12, 13;90:13; 41:13; 71:12; 79:10,12,
abnormalities 136:23; AEs 180:19,21
100:21; 106:3 92:18 16; 87:8, 25; 88:3,20, 24;
183:8; 189:6 Affairs 10:6,15
activity 32:4; 85: 10; adequate 22:5; 37: 16; 95:13; 126:6, 9; 143:22;
above 90: 1; 123:6 affect 82:6, 1983:22; 144:10; 146:6; 149:24, 25;
90:11 122:1; 127:14, 15; 205:18;
abrupt 47:5 105:19; 111:3; 175:9; 150:19; 151:5; 152:5,8,
actuai 74:3; 125:16; 206:9,12
absence 37:23; 69: 16; 184:25; 185:3; 266:1X 195:13 ;274:14,20 25; 153:1, 6; 154:5, 23;
adequately 31:1; 108:9;
160:22; 189:5; 234:17, 24; 285:11 ;289:6 affected 161:15 156:4,12, 18; 157:2,9,21,
235:18 126:16; 275:20
affecting 111:1 23; 158:11,12, 15; 159:2,
Actuaiiy 7:22; 8:15; adhere 80:9
absent 141:1 4,5; 160:3, 9; 166:16
14:13; 22:22; 25:18; affiliated 197:1
absolute 66:4; 82:23; adherent 81:4, 14 179:15,21, 23; 180:7, 16;
30:24; 34:15; 46:8, 17; afford 193:6
83:18; 174:5 57:22; 69:22; 71 :24; adjacent 85:2 181:1,4,7,8; 182:2,6;
afraid 138:9 184:10, 14; 185:1,6, 13;
absolutely 19:25; 75:1; 77:18,21 ;91:1;95:5; 98:4; adjudicated 177:13;
102:10; 111:4,12, 25; 246:5,14 African 28:24 186:1,9, 12; 187:2,6;
101:21; 113:14
112:11,21 ;130:22; 132:3; African-American 189:15; 191:12, 23; 192:6,
absurdly 113:2 adjudicating 135:9;
145:6; 146:24; 147:1; 31:19; 44:3 14, 18; 193:6, 8; 199:15;
247:14
academic 16:8; 29o: 16; 201:11 ;202:1,4;203:13,
163:2, 11; 165:8; 169:7, rnd]udication 246:! 8 African-Americans
291:5 22; 204:10; 205:10; 208:3,
10; 180:22; 184:20; 29:24; 31:10, 25; 32:2,5,
accelerate 194:22 rndjunct 204:24 4; 209:7; 215:5, 12,13,21,
222:23; 225:1; 227:17; 12; 33:4; 43:3,23,24, 25;
accept 107:7; 220:23; 233:19; 248:13; 260:16; ~djust 106:12; 108:22; 44:1; 45:2; 196:19; 200:15 22, 25; 216:2,5,6,11,13,
224:11; 243:23; 271:12; 262:2; 273:8; 285:14 118:7;131:1; 218:3,6,8, 17,23, 25; 217:3,10, 17;
AFTERNOON 179:1, 7;
284:20,21 10 218:19,21,22, 23;219:4;
acute 16:24; 37:24; 38:6, 199:5; 202:23; 203:9, 13;
~ept--l 271:12 rndjusted 108:18; 117:3; 223:3; 238:24; 252:8,10,
12; 39:24; 42:19, 21; 258:12
f’ 129:10; 199:23; 218:3 13,16,17, 21;253:16;
“ptable 66:2; 100:8; 92:14 ;93:20, 20, 23; ngain 25:19; 26:13;
adjusting 117:21; 174:6 277:10; 279:11
. .1; 164:16; 266:7; 136:16, 25; 156:12; 199:2, 27:14; 29:7; 30:18; 54:24;
270:17; 282:6 8 Adjustment 106: 1.6; Aggrenox’s 18:9
59:24; 66:13; 69: 19;
accepted 23:3; 90: 15; add 57:10; 78:3; 91:5,7, 125:22; 129:9; 218:2; 75:24 ;91:15; 101:3, 14; aggressive 102:4; 198:9
108:21; 140:25; 144:6; 18; 92:5; 118:23; 120:16; 220:11 ;230:13 107:23; 108:7, 24; 132:21; aging 49:8
189:20 147:22; 148:5, 10; 165:8; Adjustments 117:4; 153:23; 156:25; 158:8; ago 8:23; 9:1 5; 58:15;

80--0 (2) Min-u-scrip@ Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
peripheral & Central Nervous System VOL 1, April 28, 1998
—.. —
68:7; 77A; 127:25; 175:4, 12,17,18, 24; 157:10; 25; 124:7,10,15,18, 20; 130:15; 172:18; 184:24; 235:5; 236:1
6; 276:19; 286:6 160:10, 11; 192:16; 125:6,13, 17; 126:3, 20; 202:25; 292:10 argue 259:21; 262:16
ago-but 41:11 208:23,23; 213:7; 215:13, 127:17; 128:2,14, 23; anymore 103:6 argued 258:7; 280:24;
agonizing 260:17,25 14; 223:10; 224:13, 13; 129:8, 11,21; 133:4; anyone 24:15; 134:13, 284:8
230:19; 234:2; 238:25; 140:21; 141:25; 142:2,11,
agree 41:2, 5; 92:13, 25; 16; 195:13 arguing 246:12
244:8; 245:19; 284:15 16, 19; 143:10; 147:16,25
93:4; 113:7; 117:13; anyway 126: 11; 229:24; argument 36:15; 89:15;
118:1; 119:7; 135:15; along 7:20; 127:2; 230:3; 148:3, 15; 149:6, 7; 150:9,
233:15 ;292:16 222:7; 233:2; 234:9;
219: 14; 230:9; 237:23; 265:3; 273:19 20; 151:12, 12;152:12,13
anyway-but 119:4 276:16; 282:2; 283:21;
239:12; 249:12; 250:25; alpha 118:8; 129:1, 3,6; 153:16,18, 22; 154:8,18,
21; 155:2; 156:21; 158:3, aorta 48:4 289:12
251:13; 253:25; 258:16; 147:8
4, 21; 159:2, 24; 160:2; apart 99:11 arisen 155:1
259:2; 261:17; 264:14, 14; already 7:1 1; 49:2; 57:14;
266:8; 283:1, 20; 292:23 161:2; 181:16; 183:14, 16; apparently 18:16; arm 12:12, 12; 62:9;
58:14; 67:21; 82:16;
84:23; 85:10, 17; 87:2; 186:24; 189:23; 190:2, 19; 225:18 97:12; 223:23
agreeable 270:20
92:10; 112:19; 113:3; 207: 10; 208:2; 209:25; armementadum 17:21;
agreed 19:16; 30: 13; appear 23: 15; 29: 18;
11722; 132:18; 141:22; 210:15; 211:21 ;212:5,18; 202:13
65:19; 108:3,10, 11; 54:8; 105:25; 229:23
142:21; 147:20; 156:15; 213:5, 23; 220:1 1; 222:17, arms 95:24; 207:13
113:1o; 19o:6 appearance 6:1; 7:3;
210:13; 224:21; 225:23; 22; 224:2,24, 25; 225:15, arose-and 40:19
agreeing255:18 21, 24; 230:25; 236:17,25, 274:19
243:20; 252:4; 259:22, 25; around 4:4; 46:8; 73:7;
agreement 1 17:19; 260:20; 266:20; 269: 17; 242:13; 275:24 Bppeared 53:11; 124:5;
136:8; 228:18 148:7; 183:18 94:2; 105:11; 153:3;
281:7; 282:15,18, 19; tNId@Cdly 151:23 230:5; 232:13; 233:16;
agreements 250:1 288:20 appears 52:5; 106:9;
analyze 99: 17; 181 :16; 251:9; 272:11; 277:22;
agrees 269:11 alter 201:18 208:24 170:18; 181:18212:12, 282:7; 283:12, 21; 290:16,
A~A 37:20 alteration 279:19 15; 213:18; 228:3; 292:22 23
analyzed 97:22; 120:19;
aheed 36:6; 124:9; alternative 59:10; 61:19, 139:10; 182:15, 21; 183:7 rtppendix 128:11 arrhythmias 182:19
130:20; 132:16; 149:19; 24; 62:1, 2; 93:19 and/or 18:17, 22; 71:23; rnpplauds 201:9 arrived 138:15; 221:17
266:4 Although 6:25; 29:23; 72:14; 231:17; 268:6, 10; rnpplicstion 150:17; arrives 140:10
AIDS 232:8,9 31:9; 42:12; 61:7; 154:10; 280:18; 283:1 203:19 arterial 51:17 ;61:1;
aimed 200:5; 201:2 161:3; 174:3; 183:21; anemia 181:7 9pplied 15:13; 100:14; 141:15
airing 229:9 185:8; 210: 10; 230:22; 114:18; 130:6; 251:22
angina 38:1, 8; 175:24 m’tery 48:7,7, 12; 168:13
247:3; 249: 12; 265:23; Appreciate 155:6; 215:2
al 135:14 angiography 176:18 reticulate 286:6
274:22
alarming 240:19 angioplasty 38:2 ~ppreciation 17:12 wtificial 161:23
alWayS 8:1; 23:3; 44:14;
Albers 17:2,15, 19; 29:8, Ann 203:17 ~pproach 132:21 ASA 189:14; 215:13;
60:6, 6; 73:24; 93:7; 136:5;
12; 31:2, 24; 32:7, 22; announcement 5:23 approaches 11:6; 25:25 218:22; 219:4
147:24; 161:17, 18;
34:5,19; 37:18; 46:25; 232:24; 265:18 appropriate 8:9; 30: 14; Bscertain 167:17
announcements 195:22
47:3; 52:15; 53:18; 54:15; }1:8; 50:24; 109:25;
mend 270:2,9 atInUd@ 195:7; 253:10 Ascertained 24:4; 168:7
56:3,16, 22; 57:9; 58:2, 118:16; 140:24; 180:8;
12; 62:14, 18; 63:20, 24; ht?dCiI 28:23; 29:6 answered 46:24; 114:3; nscribe 25:10
[93:5; 204:5; 207:11
64:6,17, 24; 65:6, 16; American 17:16; 37:19; 154:1; 163:23; 177:22 rnside 130:14
~pprovability 15:25;
67:3, 4,8; 68:1, 12; 69:18; 48:25; 59:1, 5; 116:23 answering 246:3 aspect 111 :9; 120:12
192:11
80:20; 174:13 Americans 28:25; 49:7; antagonistic 237:5 Fn?pects30:6; 278:23
lppt’OVd 10:18; 74:11;
Alberta 94:16 195:4; 201:12; 202:14 rmti-platelet 11:9, 13; MSpiratiOn 24:17
160:16; 194:23; 196:3,4,
Alberts 199:1,4,5; mong 52:2; 103:11, 20; 13:19 !4; 198:22; 201: 10; rnspirin 10:20; 11:13;
202:24 132:1; 133:12; 135:17; rmtiatherogenic 40:11 !05:15; 252:15, 17; 259:7; 12:1,6,11,17,25 ;13:5,9,
alcohol 182:24 136:8; 154:11, 16; 210:4; !85:13
anticipate 120:19 24; 14:5, 24; 15:6,9, 18;
225:17
alerted 229:5 anticipated 145:5; lpprove 71 :4; 175:18; 19:15, 16; 20:1,7; 21:9,
mount 13:25; 21:13; !22:12; 259:24; 260:13 16, 25; 22:1, 2,8; 23:13;
akaUSe 18:15; 22:4; 169:14
)3:24; 231:10, 12;280:1, 25:24; 26:2,12,16,18,24,
71:23; 133:2,5 mtticoagulants 154:9, Ipproved 15:17; 39:6;
13; 291:23 25; 27:10; 28:12; 30:11;
all-encompassing 15 ;9:11, 13;60:18; 66:22;
AMP 89:23 [21:4; 164:8; 165:6; 33:21, 23; 34:3, 7; 35:2,
179:13 BIItiCOti@itSd 81:2
mmplified 135:18 !04:21, 23,24, 24; 257:22; 24; 36:1,8,17,22, 25;
allegation 165:21 rnnticoaguktion 50:20
Bmplify 135:25 !60:1, 8; 262:4; 264:13; 37:1, 11,2Q 38:2, 13,13,
allocated 99:2; 102:2 antiinflammatory 92:6, 19, 22; 39:5; 40:25; 41:12,
analogous 233:25 !69:23; 282:16, 17; 285:1,
allocation 104:3 24; 93:10,18 22;42:5, 7; 43:10, 18;
17
a110W5:17; 45:22 ;81:10, NIF@f3S 58:3, 5,6; rnntiplatelet 26:17; 27:7; approximate 243:14
i5:21; 51:6,7; 52:10; 53:7,
)7:19; 105:23; 111:11; 13, 17; 54:9,24; 55:4,13,
17;86:13; 179:17; 205:4 29:13;31:4,11,16; 35:11,
123:1;126:1; 141:21,21; Ipproximetely 13:24; 13, 15; 56:2; 58:19)21;
allowed 81:2; 146:25; 13; 50:25; 51:3,10,13,19,
142:4,8, 13; 150:10; !1:16; 34:24; 86:20; 59:20,23,23, 25; 60:24;
266:12 25; 52:4; 53.6,8,11, 21;
153:15; 160:5; 163:13; )5:25; 127:20; 137:20; 51:4,13, 25; 62:3, 22;
allows 69:22; 80:23; 59:10; 61:20; 65:7,21;
182:20; 183:5; 207:4; [53:7; 197:14 ;214:11 53:5,6,7,18,21,21,23,
149:22 56:19, 22; 73:22; 80:21;
208:1, 22; 223:12, 17; 4pril 249:25 25;64:13, 16, 17; 65:24,
?3:22; 154:9, 15; 184:1;
dmOSt 74:18, 25;75:18; 236:14, 18; 240:21,24 25;66:15;67:11, 15;
202:5 wbitrariness 278:19
82:23; 85:3; 112:8; malysis 21:3; 97:14; %: 10,23, 23; 69:2,6,6;
117:19 ;181:10 Rntiplatelets 41 :24; wbitrary 25:16
W:1O, 16; 101:9; 102:1,6, 70:6,8,18,22, 23; 71:1,5,
alone 11:9; 12:1, 5,7; 196:18 wcane 229:8
17; 105:15; 107:17; 108:2; ?, 14;72:17;73:11, 13;
22:6,8,18, 18;43:14; 109:8,14, 23; 110:13, 17; Antithrombotic 17:18; we-but 280:25 74:9; 75:22; 79:15,20, 23;
68:4; 69:6; 70:8, 13; 71:11; 111:1,18,19; 116:4; 38:14; 80:24; 90:11; 92:2, wea 82:14; 199:13; 31:22 ;82:8,12,21;83 :1,
73:6,10,19, 24; 88:13; 119:5; 120:3,4; 121:7,11, 3 !30:20, 20 24; 84:5, 20; 85:8; 87:7,
91:3; 95:2; 129:18; 12, 13, 14; 122:6, 14, 16, my--we 220:19 lreas 133:24; 172:21; 11, 16, 25;88:12, 13;91:2,
136:19; 147:20; 148:10, z1; 123:5, 10, 16, 17,22, anybody 74:2; 100:15; [82:21; 207:17; 225:13; 3,14, 15; 92:5,8, 23;

Miller Reporting Company, Inc. M.in-u-seriptm) (3) ago--but - =pirill


,Advi80ry Committee Food and Drug Adminktration
Vol. 1, Auril 28, 1998 Peripheral & Central Nervou8 System

93:10,15,17,23, 24; 94:9, Association’s 1%:10 114:16, 18; 115:5,6; beet 45:14 ;218:23 19; 265:4
10; 95:2,7; 108:7,8; assume 115:7; 234:8; 146:22; 149:14; 230:11, beats 218:21 benefii-risk 192:16
~~5; 119:14,23; 126:5; 238:20; 243:13; 256:12; 17; 232:16; 233:6; 237:16 become 146:4; 179:21; benefiirisk 180:10;
‘4,8,9, 21; 144:11; 257:2 b.i.d 26:5,11 195:16 ;250:20 187:6
,.7, 15; 147:15,17,20, Assuming 144:16; Babette 27:6 becomes 113:20; 277:13 beneficing 163:4,6
21; 148:11,17, 24; 149:9, 238:13 baby 144:10; 146:7, 15; bed 38:21 benefiis 12:3,7; 14:14,
9; 150:1, 18; 152:6,8, 16;
assumption 107:15; 195:15 ;265:5 beds 48:22 14; 26:18; 30:11; 39:19;
153:1, 12; 154:3, 24;
109:5 ;231:2,4 back 7:25; &20, 21;9:23; 40:8, 12; 41:4,14, 25;
155:21; 156:2,12,18, 23; been-in 157:12
assumptions 109:11, 10:1; 20:24; 24:12; 41:16; 42:11,23; 71:16; 88:3;
157:3,10,13, 21; 158:8, begin 10:4, 23; 252:22
12; 122:3; 125:22; 141:25; 45:6; 57:5; 64:23; 691 1; 124:4; 154:6; 160:3;
11; 159:1; 160:10; 165:4, beginning 30:12; 122:3;
239:10; 259:13 71:7; 76:17; 77:5; 794; 187:4; 238:1; 239:16
4,6,17,22,24, 25; 166:7, 123:16; 221:16; 2272,9,
assurance 44:10 88:9; 93:2; 103:11; Bertrand 98:6, 9; 104:1
10,16, 16; 167:2,5,7,10, 11;232:15; 284:18
11; 172:1,15,21,22; assure 5:7 114:21; 116:1, 13; 124:23; BERTRAND-HARDY
1393; 145:25; 149:20; behalf 37:14; 45:24; 98:12,22, 24; 99:1,9,20,
173:5; 175:14; 179:25; ate 242:16
155:4; 163:18; 164:15; 194:11; 1%:20 22; 100:2,6, 12; 104:18,
180:21; 181:6,8,10,12,
atherosclerosis 47:16, 191:21; 203:3; 217:14; behaves 32:11 24; 105:4; 114:12, 15;
18; 182:1; 183:21, 23;
17; 48:3, 6; 50:23; 92:12 229:21; 234: 14; 277:7 122:10, 15; 131:23
184:10; 185:5,14, 25; behaves-dipyridamoie
atheroscierotk 23:19; back-this 288:1 32:11 besides 104:15
186:14; 192:2,15, 21;
40:21; 4719; 48:8 best 107:14, 16; 129:15;
193:3,4,6, 10; 204:11,12, background 21:24; behaviors 201:18
16; 208:4, 12; 209:9; atriai 47:25; 50:19; 22:12; 28:5,8, 15; 79:14; 132:21; 151:13; 259:4;
behind 84:21; 17721
210:9, 25; 213:8,19,20, 195:20 134:8 290:10
beiabor 45:5; 134:23
21;214:13, 19,22; 215:14, attached 81:3, 11; 82:6 backgrounds 28:16 beta 147:2
Beigium 98:11
22;216:2,6, 13,23; 217:1, attack 23:1,15, 17; backwards 257:25 better 56:20, 22; 58:5,6,
4, 18; 218:9, 23; 219:2; believability 224:14 8; 60:20; 72:5, 19; 89:13;
37:25; 198:6; 212:25 bad 117:19; 140:4; 221:5
223:2,9,10 224:18; attacks 23:14, 16; 141:7 believable 224:6 90:16; 146:21, 21; 149:2;
238:24; 243:22, 23; 244:9; baiance 65:9; 96:22;
attempt 61:18; 62:14,23, beiieve 18:20; 20:25; 191:1 ;211:2;221:19;
245:14; 258:2,6,9, 19; 180:20; 186:3; 246:25
24; 191:10 37:6; 39:13; 40:16; 57:2; 223:10 ;238:18;245:18;
259:20,22, 25; 260:8, 20; balanced 96:7; 206:13; 70:1 1;71:4; 90:14; 249:18; 254:22; 258:22,
262:20; 263:1,14, 16; attempts 253:3 210:2 112:20; 114:11; 119:3,4; 24; 276:7; 285:25; 287:19;
264:1,2,7,10,10, 19; attend 16:23; 19:6 baiipark 56:7 12616; 148:6; 154:18; 289:13
265:5; 266:1; 273:17, 18, attendance 16:9 base 133:13; 261:3 155:10; 160:13; 187:1,25; beyond 71:21; 113:5;
25; 275:1, 4,5; 279:15, 20; attention 17:22; 85: 16; 201 :25; 223:2; 224:9; 244:24
Based 6:2; 12:14; 28:17;
+--1, 2, 5, 11, 14; 284:15; 88:6; 90:2; 153:10; 157:1; 227:14; 241:10; 243:21;
29:2; 41:3; 43:1 1;44:8; bias 118:3; 192:9; 206:12
},21,25;286:10,11, 161:9; 202:22; 225:25 251:18; 269:23; 275:10;
53:20; 58:14; 71:5; biased 229:16
Lu, 20 102:19, 25; 105:25; 109:6, 280:1, 2; 283:9, 24; 284:6;
attracted 222:23
aspirin-13 21:16 290:1 5; 292:24 biasing 283:24
attributed 250:10 11; 113:19; 117:2, 10;
aspirin-you 263:10 120:5; 133:4; 139:11; beiieve-and 29:3 big 56:13; 113:23;
audience 9:21 164:10; 192:25; 235:3
aspirin-alone 62:9; 154:12; 160:13; 166:22; beiieve-that 29:4
August 129:7; 150:21 bigger 240:11
184:13 193:1; 198:18; 212:19; beiieved 27:17; 89:22;
author 17:16 223:13; 226:3,4,8,12,16, biggest 185:10
aspirin-induced 26:13 244:8
automated 81:12 18, 22; 227:17, 23; 228:9; biiiion 49:14
aspirin-related 14:9; beiieves 39:10; 2004
autometicaiiy 110:1 245:25; 247:25; 252:9; biiis 201:6
186:19 BELLE 4:6, 6; 9:5; 110:2,
avaiiabie 8: 19; 19:16; 253:8; 261 :8; 278: 12;
aspirin/placebo 151:4 12; 112:3; 132:7; 143:16, bind 86:6
54:8; 57:11; 62:25; 63:13, 279:9
aspiring 209:8 18; 144:8, 21; 145:21; biochemical 40:2; 84:22
16;65:7; 66:25 ;67:18; baseiine 154:13, 13;
assess 30: 10; 80:23; 262:11, 12; 270:3, 18; biological 36:21; 89:15;
68:23; 144:17; 146:4; 182:15, 18; 183:6; 206:13;
133:3; 167:20; 176:8; 271:10; 278:17; 291:1,3 206:1
188:1; 195:3; 196:5; 225:16
177:1; 179:18 beionged 114:6 bioiogicaiiy 81:16
198:15; 201:21; 202:11, basic 12:5; 40:6; 121:1;
assessed 24:10 20; 248:1, 4; 259:1; 265:6, 127:5; 146:20; 231:22; beiow 190:16 biostatistician 88:4
assessing 167:24 7,9,10 246:23; 257:18 Beit 199:9,13, 19; 200:9, Biostatistics 230:2
Assessment 16:19; average 82:9; 124: 1; basicaiiy 22:14; 67:1~ 19; 201:8,9
bit 28:6; 43:2; 51:9; 52:5;
19:23; 24:8; 100:18; 190:3; 199:22; 200:15; 76:10; 132:9; 145:23; beneficial 18:19; 19:10; 58:6; 67:5; 72:24; 76:17;
101:23; 125:7; 133:1; 241:15 150:5; 182:14; 209:11; 25:25; 38:3; 39:24; 40: 17; 77:18; 91:25; 103:22;
135:14; 163:20; 176:25; avoid 5:4; 254:5 211 :7; 238:17; 246: 16; 50:13; 75:20; 166:23; 116:7; 122:15; 124:24;
180:10; 187:6; 211:13; 250:20; 266:8 192:2; 260:11; 284:2 143:20; 144:21; 174:20;
avoided 222:2o
246:19 aware 7:12; 32:15; 84:24; basing 259:6 benefii 13:7; 31:3,6; 184: 17; 207:23; 233:20;
assessments 105:24 basis 9:18; 11:23; 35:22; 34:16; 42:14 ;43:20,21; 283:20
103:20; 104:5; 139:18,25
assignment 114:9 39:2,3 ;41:1,10; 92:21; 50:16; 52:5; 54:9, 18; biah-biah-biah 264:2
Awareness 195:17;
93:5; 97:21 ;98:19; 101:1; 55:19; 57:13; 61:12; bieeding 26:23; 35:9,23,
assistance 129:4 201:7
102: 13; 103:9; 110:3; 68:25; 69:5; 71:9,11,13,
Associate 18:3; 199:1,6 away 49:25; 118:23; 24; 36:3,4, 10; 97:7,7;
111:17; 121:6 ;125:6; 22, 25;72:4, 11,16,17, 98:15; 105:25; 170:18;
associated 35: 14; 174:11; 242:17; 253:15; 18;73:3; 75:13 ;80:21;
133:20; 135:17; 177:7, 15; 181:5; 183:20; 184:2,4,7,
_&-+.22; 202:17; 213:11; 254:23; 259:19 82:13; 84:19; 94:10;
192:9; 193:3; 233:8; 9, 11; 185:2,4,11,18, 23;
5, 16, 17; 235:18; awfui 221:23 250:23 109:12, 17; 167:1,7;
186:19 ;214:14
Lad.“8 173:9; 174:19; 187:24;
bath 164:20; 165:11 biended 117:11
Association 48:25; 59:6;
70:15, 16; 175:3; 183:23;
B be-1 57:13
193:2; 208:24, 25; 210:13,
1~211:9, 19;212:12, 21; biind 107:23; 133:2;
194:6,10, 13; 195:1, 18; beans 272:6 213:7, 18, 24; 221:9; 206: 15; 274:20
196:21; 197:2,6 B 99:24; 104:13:110:5: bear 182:12 241:25 ;242:1,7; 260:13, biinded 100:20; 105:23;

aspMn--l3 - blinded (4) Min-u-scI’ipt@ Miller Reporting Company, Inc.


Food and Drug Adminktration Advkory Committee
peripheral & Central Nervoue Syetem VOL 1, April 28, 1W8

110:4; 117:2; 131:11; breaks 49:15; 222:13 292:14 Care 4:18; 16:17; 49:17; cell 80:6
140:3; 253:12 breakthroughs 1%:1 Califf’s 7:5 147:20; 161:23; 162:23; cell-free 81:9
blindly 100:23 breath 192:25 Call 4:2; 79:7; 105:4; 170:6; 188: 18; 199:2,8, CdS 81:8; 85:25; 145:2,
-=
-3. 25; 200:2; 206: 14; 244: 15;
blindness 99:3; 115:2 brief 140:2; 203:10; 215:1 134:21 ;135:11; 152:12; 7,14, 17; 147:7
. 274:18
blood 47:6,9,10, 14; briefly 19:6 20:24; 95:19, 158:3; 244:10, 25; 247:17; censor 236:6,8
80:9, 16; 81:2,9, 25; 249:19; 257:8; 267:25; careful 259:8
20; 150:24; 179:20; censored 232:4; 290:7
85:25; 89:6; 182: 18; 194:12; 252:23 268:1 5; 288:22 caregivers 194:15
Ct?MOdng 232:4;
255:10; 257:17
bring 8:10; 33:15; 68:14; called55:10; 59:16; cares 271:25
271:14; 290:5
blue 21:12 129:15; 139:19; 155:4; 102:16; 105:5; 135:3, 8; Carlo 27:5
Center 4:9, 11;6:5,20,
board 23:20; 196:10; 164:16; 225:24 138:3; 140:12; 141:18 CarOiina 199:3,7, 24; 20; 16: 13; 17:15; 96:9;
197:4,5 brings 15%6 calling 251:19 200:24 153:20; 1%:13; 197:2;
boards 113:16; 130:24 British 172:7; 173:7 cams 22:2; 84:16; 123:5; carotid 34:14; 50:12, 21; 199:7; 2104
Bob 4:19; 18:3; 36:6; 153:18; 163:2; 208:2; 55:6,9, 23; 154:23; 210:6,
broad 40:23; 191:11; centers 14:20; %:3;
76:11 ;103:11; 113:8; 254:23; 280:9; 285:15 9
194:16 100:22; 103:4; 160:19;
148:19; 167:4; 168:19; can 5:7, 19; 15:1, 21; carried 135:5, 8; 162:18;
broadly 125:5 207:3; 209:24; 219:19
169:4; 230: 1; 231 :9; 19:1; 20:24,24 ;23:11; 258:18; 259:9; 289:23;
broken 53:23 Central 30:14; 103:4;
235:9; 236:13; 237:7; 36:12; 37:14; 39:15; 290:19
135:9; 177:14; 246:6;
241:24; 288:18 Brooke 9:5; 94:15; 41:15; 43:23; 44:17; CtirdS$S60:8; 159:9
247:14
101:19, 21; 102:4; 115:18, 47:11,17 ;48:1,6; 49:16; carry 74:24; 122:13
Bob’s 113:24; 281:5,11 centralized 96:6
19; 161:12, 13; 176:20; 50:16, 19; 52:22,23, 24;
body 136:23 carved281:8
177:3; 250:17, 18; 257:25; 54:2,3, 16;55:11, 16; cerebral 162: 16; 188:8,
Boehringer 10:4,7,16, 268:9, 12; 271 :22; 272:5; cascade 80:17 12
57:23; 60:4; 63:3; 65:12;
18; 12:8; 17:9; 98:9; 273:25; 281:18; 290:5 case 8:6; 23:1 1; 49:18; cerebrovascular 67:12;
66:14, 19;68:1, 14, 19;
179:10; 199:16, 17; Brooke’s 279:15 74:13; 98:15; 109:7;
69:1; 74:8,14,19, 23; 200:5; 276:18
246:16 112:10; 132:2; 135:21;
brought 8:5; 90:2 63:4, 9; 86:6; 98:4; 106:2; Bertain 24:14; 25:5;
Boehringer-lngelheim 138:11,21; 161:2; 163:19;
Brown 16:10 110:20,21; 111:14; 112:7, 121:8; 122:8; 133:15;
88:5 164:18; 165:24; 176:3, 8;
22; 113:9; 114:23, 24; 134:12; 150:6; 225:6;
Brussels 105:1,3 215:12; 217:16, 17; 224:8;
Bonferoni 112:9; 113:2; 115:7, 21; 116:9; 118:3, 231:12; 259:12
~uck 262:13 242:9; 243:23; 244:14;
129:8 15; 119:2,9; 124:11; :ertainty 22:4; 28:24;
3uilding 6:14 247:25; 251:20; 253:12;
booklet 221:17 126:13; 130:2,16,17,18, 56:7; 57: 11; 63:16;
260:12; 279:2; 281:22
wilds 191:24 20; 133:9, 15; 138:6; 106:17; 117:4; 163:12;
books 123:19 CaSe-Sp*ifiC 185:4
milt 92:2;102:19 139:6; 141:3; 143:15; 170:5; 171:25; 189:17;
— . boomer 195:15
_=—. milt-in 102:20 146:12; 155:3, 4; 163:8; cases 240:3; 248:12;
191:13; 206:9; 207:12;
Boston 4:11 165:18; 166:16; 169:18; 253:14; 292:6
mrden 49:12 213:11, 17; 234:15;
both 5:7; 11:9; 12:5; 174:8; 175:24; 176:10; ~atch-22 72:10; 113:20 Z36:25; 249:12, 21;
14:24; 15:5; 29:9; 40:1; mreaucrats 292:20 181:16; 186:23; 188:7; Batego ries 50: 21; Z65:13; 275:11; 291:3
42:17; 71:14, 17; 77:3; 3ush 195:20 190:8; 192:6; 194:2; 210:19 ;211:15;212:6,11, :et’tainty 243:10, 14
79:23; 103:3; 109:20; xtsiness 23:2 195:12, 13; 1%:5; 197:25; 19; 214:6
121:15; 123:21; 142:25; ~05:21; 207:7, 15; 208:7; certificate 140:10,22
IUsy 90:4; 180:13 :W?gOriZSd 137:24;
147:6,9, 25; 148:1; 149:1, ~IO:7,22; 212:20; 213:l; :ervical 47:16; 48:4
wt-but 45:15 184:23
2,8, 17; 153:2, 12; 155:18; ?18:17;219:5; 220:21,22, :essation 99:11; 150:25;
156:22; 158:25; 159:25; WY 166:16; 290:14 ?4,25; 229:25; 230:10, 10, :ategory 138:8; 139:9;
51:7, 19; 181:22 ;214:8,
160:3; 164:22; 166:18; mying 36:15 ~2;231:24;241:23; 212:24; 214:21
,0,12
171:6; 173:15; 190:16; }ypass 38:1 ?46:24;248:7, 10; 251:8; 2ATS 59:16
:etera 76:2
191:11; 192:1; 195:12; !55:15; 258:9, 22; 262:24; :aught 77:3
:hair 113:15; 130:23;
207:13; 208:24; 215:14;
224:1 1; 226:17,19, 20; c !63:19; 264:21 ;266:14;
!67:10, 19,21, 23; 270:25;
:ause 20:6; 22:6, 18, 24;
~3:22; 24:2,4,10, 13;
,97:3
230:16, 17; 240:10; !72:17; 274:23; 277:12, :hahd 21:25
25:3, 11;45:18; 47:7, 17;
244:20; 265:2; 269:14, 23; : 99:24; 104:13; 110:5,6; [6, 18; 282:6; 286:14, 15; [8:6, 12,19, 20; 133:3; :hairmen 16:10, 18;
275:14; 276:16; 280:19; 14:16, 18; 115:5,7; !87:22; 288:1,3, 25; 292:9 [34:15, 17, 21; 140:11,17, !4:8, 11;79:6; 100:17, 19;
289:20 31:13; 230:11 :anadian 43:12; 116:22 ?0;168:7,8; 169:10; 33:18; 187:17; 192:24;
bother 121:2; 276:1 :alcu[ated 52:22; 127:13 [97:16, 17; 21 1:12; 250:4, 94:8; 1%:9, 12
:ancer 96:5; 164:21
bothering 103:19 ); 257:16 :hance 68:19; 142:9;
:akulating 227:16 >APRIE 60:24; 61:8, 10;
:ause-specific 169:11 92:9; 220: 1; 238:18;
bottom 125:23 calculation 122:2; ;2:4, 6; 63:4, 19,21,23,
!50:7
bottom-line 139:4 !27:16 !4; 116:25 :aused 50:14
:hange 9:10; 19:1; 88:20;
bound 75:22 calculations 109:6 :apsuie 13:23; 144:19 :auses 20:15; 22:13, 14;
16:3, 17; 130:16, 16;
boundary 130:11 :ALIFF 4:19 19; 6:18; :aptured 184:23 !3:5, 19; 47:23; 48:7;
65:13; 211:13, 25; 237:8;
‘:8;28:3, 4; 3&14> l>; >arbondale 4:13 [34:2; 168:11; 170:18;
boy 263:14 !50:9; 253:5; 259: 17;
5:4, 5; 64:20; 65:2; 76:15, 189:2;
212:2,3
bracket 182:22,22 :ardiac 47:24; 50:22; !76:1
6; 77:16; 78:2, 13;79:3; )3:13; 134:19; 170:17; :aution 61:16; 62:20;
brain 10:22; 11:21; 18:11; :hanged 227:18,23;
)1:23, 24; 93:1, 11; 94:4; .82:17; 205:1; 209:10 [58:2; 177:24
47:6,7,11, 12;48:2; !50:11
01:19; 102:9, 20; 103:10; :aveet 22:7; 239:4
163:5;
168:14;
254:17,
20; :ardioemboli 50:18 :hanges 8:21; 107:6;
—%=
_.—- 17:7, 8; 118:17; 167:4, :aveets 243:6
257:10,17 :ardioembolic 65:21 .18:3; 189:20
4; 168:4,8, 12; 171:3,11,
break 48:2; 78:20, 23; cardiologist 136:6 2BC 60:9 :hanging 194:I9;
5,21;
221:15,20,25;
79:1; 155:4; 164:16; :31:9; 242:12; 243:3,8, cardiovascular 167:22; 2BCS 60:10 96:22; 259:5
193:24 2;250:3;
261:1,2; 70:25:171:2:172:20: 2DC 200:3 characteristics 142:6;
breaking 118:10; 224:7; :68:14
;271:11;
283:14; 74:24: 25; 175:3; 182:18; :eased 96:12; 151:1,5, 54:13; 259:5,6
274:19 85:5,
10;289:10,11,
25; !37:25 ,0 characterized 179:25

MWer Reporting Company, Inc. Min-u-script@l (5) M.hUy - characterized


~dvisory Committee Food and Drug Administration
‘VOL 1, ADril 28, 1998 Peripheral & Central Nervous System
-—
Charles 16:13 clearly 28:22; 30:16; Coiorado 194:6 coming 8:21; 28:19; 59:4; 156:19; 157:3,9, 11;
Charley 39: 10; 119:7; 31:13; 66:3; 78:8; 80:21; coiUmn 215:18,24; 88:9; 100:22; 250:24; 189:17
172:5; 237:21; 240:2 82:13 ;91:4;92:22; 125:1, 216:8,14,15, 25; 217:18; 286:17 comparator 64:13
_&% 20; 128:10; 145:24;
e 105:21 218:19,22 comment 7:18; 8:19; compare 33:22; 99:18;
150:17; 152:24; 166:4; combination 11:9; 12:6, 22:22; 24:10; 25:7,9,9,
G.. -ck 57:1; 142:4 101:11; 143:8
183:1; 279:1 13; 26:14; 29:8; 32:20;
Chest 17:17; 24:23; 11,17;13:4,7, 14;16:3; compared 13:5; 34:15;
37:19; 59:2; 134:20, 21;
ciients 290:11 25:24; 53:12; 61:21; 62:9; 34:17; 41:16; 76:16; 44:3; 4610; 51:20; 54:21,
ciinic 14:14; 29:4; 93:6; 63:11; 65:25; 66:15; 78:15; 85:11; 89:1; 90:22,
250:10 24; 56:21; 60:23; 62:2;
115:22; 192:1; 250:20; 67:15, 19;69:2, 5;72:4, 23; 93:10; 98:4, 6; 100:18;
Chicago 4:16; 196:14 112:7; 113:7; 116:19; 69:6; 110:7; 214:12;
257:3 18;79:15, 19;81:21; 218:18; 243:10; 277:1;
Chief 16:12 117:7; 120:1, 23; 133:19;
Ciinicai 6:19,21; 17:7,8 82:12, 21;83:23; 84:20; 284:15
children 272:5 87:24; 88:12; 91:2, 16; 140:2; 144:21; 146:18;
21:21; 307; 37:17; 38:14;
choice 33:21; 50:25; 95:2, 12;110:9; 111:21; 15024 ;248:10;251:11; compares 54:19; 189:15;
39:4,15,18, 19; 40:2,6,7,
74:5; 229:11; 269:15 119:12,13,14, 23;131:13, 255:15; 260:15; 266:17; 215:19
8;41:1,4; 47:2; 74:15;
choices 64:25 80:18, 20; 88:3; 92:24; 14;144:2,3, 18;145:16, 274:6 COftIpdIg 59:21; 64:12;
93:3, 24; 94:19; 95:5; 17;146:10,17,19, 20; commented 25:23; 26:1 143:5
cholesterol 183:9,9
108:21, 21; 113:10; 147:19; 148:4,10,16, 21; comments 56: 1; 110:12; comparison 30: 10; 34:5;
choose 26:2; 27:12, 13;
120:25; 133:12; 134:8; 149:2,11,14,14, 15; 176: 18; 1%:23; 222:2; 4013; 44:4; 54:21; 55:1,4;
224:9; 230:7; 259:3
135: 17; 136:2; 137:9; 151:25; 152:21; 155:22; 245:8; 251:24; 254:1Q 61:23; 62:13 ;65:14; 66:9,
chopped 153:9 158:16; 160:23; 202:6, 9; 278:21
139:12; 141:8; 170:12; 14; 67:1 1;68:22; 69:17;
chose 26:5; 230:14, 15; 174:13; 183:25; 185:15, 203:23; 204:10,15, 20; commitment 197:10 81:20; 111:21 ;124:12;
270:20 20; 186:11, 22;188:9,13, 205:4,4,7, 11;207:10; 131:9; 149:12; 231:21;
committad 74:9; 200:18
chosen 12:18; 14:6; 20,22;191:25;
202:5; 208:11, 16;210:14, 16; 232:15; 233:7; 237:15
comm”htee 5:5,8; 6:7;
23:24, 24; 59:23; 142:16 206:10;209:20;
217:25; 211:18; 212:12,20;
213:24 ;215:10, 11,15; 8:1,2,6,10,11, 12;9:3,6, comparisons 21:4; 34:7;
chronic 38:1; 42:22 226:12;232:11;245:2;
221:7; 223:6,21,22, 23; 10,12,15,19, 23; 10:10; 35:12; 54:13; 55:21;
church-based 201:5 259:12;271:17;
275:13;
224:2, 14;234:20, 24; 15:16; 1 7:12; 20:4; 24:8,9; 61:23, 25; 62:24; 63:15;
289:7
cigarettes 182:25 244:14; 245:18; 253:3; 30:14; 39:22; 40:1; 76:7; 64:11 ;65:3;66:4; 93:14,
clinically 27:19; 38:3; 78:9; 94:21; 97:21; 98:7, 16; 94:12; 126:6, 12;
circulation 188:9, 13 258:2,7,12,22, 23;
183:2, 10; 230:9, 22; 101:10; 145:20; 147:17, 23;
circumstance 55:22; 245:6; 246:9; 253:4 259:15; 263:6,8,11,12, 13,17, 18;100:25;
137:23; 145:11 102:12; 103:2,5,9,11,18, 149:13, 22; 152:6, 22;
20,23;264:9,13,17, 18;
ciinician 29:7; 65:8; 25;104:12,16, 16;105:1, 153:11; 156:6, 25; 158:10;
circumstances 110:11; 265:5,8,11, 16;274:2;
285:17,19 7,22;108:1,3,6,6; 159:3; 192:13; 216:12;
188:18 276:7; 277:1; 280:6;
clinicians 64:7; 65: 12; 110:16, 22; 114:4; 125:8, 220:19; 231:23; 275:17;
gin:-gms 37:21 284:15; 285:2, 23;286:19;
276:5
227:6; 259:23; 286:4 287:14, 18;288:9; 290:20; 11;127:6, 6;130:18;
I 39:9; 73:11; ciopidogrei 46:1; 51 :6; 135:9; 137:14,21; 138:21, comparisons-the 35:12
291:24
132:16; 260:20; 267: 1; 60:18; 61:3,5,7,12, 20; 24;139:16; 152:25; 161:9; compatible 182:5
273:7,12, 23; 278:25; combinations 215:11;
62:4; 63:5, 10; 65:24; 66:8, 166:5; 168:6; 177:14, 24;
259:3; 262:2; 265:18 compelling 35:17; 74:10;
288:18 11,16;116:25; 285:4,5 178:3; 179:12; 182:12;
combine 13:18; 54:5; 166:5, 14; 192:5; 245:6
claimed 146: 13; 205:6 ciose29:19; 34:11; 189:20; 191:9; 194:9;
159:20; 258:4; 262:5; 1%:2,4;197:8; 201:10; competing 6:17, 23;
clarification 57:21; 57:14; 85:4;86:5;181:14
226:7; 267:10
266:12 238:16, 16;246:6; 247:14, 231:6; 239:11; 242:18
cioseiy 156:18;168:7 combined 10:20; 11:19, ZO;252:2; 253:9, 11,24; Compilations 29:15
clarifies 123:18 cioser 35:7; 118:18, 19 24;15:15; 18:10,21; ~60:8, 8;2(52:25; 267:18; compiete 27:1; 123:5;
clarify 103:22; 114:4; ciosest 292:13 19:17, 21,24; 22:9; 41:7; Z(59:11; 273:11; 274:14; 127:18; 143:9; 151:18;
121:9; 122:18; 174:1; 51:7,11,18, 20;53:8; 277:4
ciots 48:1 191:18; 250:16
278:8; 292:16 54:10; 61:1,2; 71:6,25;
cluster 190:10 >ommittee’s 7:9; 203:16; completed 10:22; 14:19;
clarifying 90:23 72:7; 73:1,2,5,16, 23; Z62:9
clustering 191:1 18:11; 59:15; 254:17,20;
classic 147:16 74:4, 16;76:1; 77:9,10, :omm”htees 30:13; 257:11
co-worker 98:9 12,12, 25;78:2,4;91:14;
classical 231:22 101:12; 103:3; 104:23; completely 26:6; 33:6;
Coagulation 4:21, 23; 103:17; 112:1;128:5, 24; ~90:8
classification 212:19 92:13 ;141:1; 156:1;
8:8 143:1; 168:20,20,23, 24;
classified 24:21, 22; :ommon 45:18; 47:22; 159:25; 188:10
coat 38:16 175:19; 186:13; 204:17;
211:12; 212:8; 235:14 210:25; 211:14; 213:2,6, 52:25; 102:10; 131:6; compiex 80:18
coating 14:1 171:5,7, 13; 181:21; 182:4
Claudia 6:1 1; 10:3; 274:6 11,15;214:17; 229:19; compliance 12:21; 14:4;
code 118:10 :ommonly 48:7; 202:17 202:10
ciean 157:24; 220:25 234:1,14;236:21;238:17,
codes 185:7,8 25;239:22;240:22;242:4, communicated 127:9; complicated 111:5;
cleanest 118:13
COff= 182:24 7,11;254:15;257:9; 245:11 265:16
ciear 12:3; 43:20; 44:12;
58:7, 8; 66:6; 68:25; 71:13, cognitive 198:13 267:23;268:10;271:5,6, :Ommunity 200:8; 275:2 complications 42: 17;
16, 25; 72:3; 76:12; 95:14; collaboration 26: 18; 8;277:11;280:5;283:22, :ompanies 6:22; 75:11; 205:1
101:21; 123:19; 128:12; 51:13 23;285:12,21;286:11; 199:11 complies 16:2
131:1o; 160:4; 161:1o; collaborations 35:13
287:5,8;289:19;290:17;
sompany 69:20; 75:7; component 23:24; 41:9,
166:21; 172:4; 175:22; 292:15,25
coilagen 80:9 100:15; 101:16; 103:20; 13; 72:19; 74:18; 77:1;
191:17; 215:1 ;221:8; combines 87:13, 25; 104:2,16, 22; 110:21;
colleagues 18:8; 193:14 78:5, 7; 147:9; 148:17, 18;
2=21; 239:20; 247:3; 202:4; 242:6 116:9; 146:16; 199:17;
coiled 187:18 149:24; 180:8; 181:1, 17;
F ‘“6; 269:20; 272:17, combining 159:15; 221:19,20; 253:21; 183:15 ;186:18;205:5,6;
A;273:10, 11;276:8; coiiected 136:2; 183:6 258:14 254:14 ;255:11;257:23; 207:13; 232:1; 245:18;
278:2; 279:23; 280:21,24; collecting 174:25 combo 231 :22; 233:4,5, 291:15, 20; 292:1 287:15, 23; 288:5; 289:5
282:9; 291:20 COiieCtiOn 235:12 6 comparable 15:6; 56: 18; components 13:14;
clear-cut 24:14, 19 Coiiege 17:16; 37:19; comfortable 239: 19; 52:17; 643, 4; 65:5; 14:13; 16:5; 18:20; 72:2, 6;
clearer 275:7 59:1 246:13 ;253:19,21; 256:1 126:11; 154:5; 155:17; 77:3; 81:23; 95:1; 111:22;

Charles - components (6) Min-u-script@ Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
Peripheral & Central Nervous System VOL 1, April 28, 1998

126:7; 142:25; 143:3; conclusion 66:15; 68:24; 113:5 contributing 236:9 209:24
146:10,13, 22; 148:23; 69:22; 76:4, 5; 112:16; consideration 17:13; contribution 9:16; 13:9; country 11:5; 33:18;
149:1 ;152:1; 154:6; 134:13 ;141:2; 151:14; 203:15; 225:16; 266:21 164; 19:15 ;71:19; 109:3, 144:7; 201:22,22
155:18; 159:5; 160:4; 154:1; 156:8; 160:3, 13; considerations 204:7; 4; 148:5; 152:20; 181:17; country-which 146:5
179:24; 180:4; 191:25; 180:10; 186:11; 187:6; 233:15 183:14; 185:8, 10; 205:5; countrymen 197:13
204: 15; 205:12; 208:2; 190:25; 191:2, 5,7; 211:24; 236:3; 237:20;
considered 8:1; 139:15 counts 237:7
210:17 ;211:14;213:24; 192:14; 193:1; 240:14, 25; 245:21; 287:15,23
218:24; 220:22, 24; 253:15 considering zol: 10; couple 7:24; 9:14; 18:23;
contributions 158:20;
223:21; 231:25; 236:4, 6; 206:19; 209:7; 225:2 30:22; 49:10; 252:4;
conclusions 70: 1; 156:9; 185:9; 211:22 ;241:19
240:8; 241: 18; 253: 17; consisted 141:13 2til; 281:18; 284:17
159:6; 16&8; 191:21 contributor 22:15
254:22; 284:2; 288:20 consistency 24:14; 25:4; couples 281:23
conclusive 12:4; 71:16; control 68:11; 80:13;
composite 18: 16; 245:17 142:5; 155:13; 161:2; course 920; 24:12;
83:19; 117:11 30:15; 64:10; 67:21;
124:19; 128:8; 129:14; 166:15; 207:2; 219:18;
concomitant 154:9, 15 controlled 157:13;
141:12, 17; 150:13; 158:5; 220:3, 13; 225:6; 244: 18; 22:20; 98:22; 99:1 1;
167:23; 190:15; 208:25; concur 169:16 273:15; 275:1 5; 276:9 167:6; 206:9; 265:6 100:25; 1056; 107:5;
211:19 ;218:15;221:12; concurrent 205:8 consistent 15:8, 15; controversial 141:6 115:11 ;121:5; 124:9;
226:3,8,13,16,18, 23; condition 188:20; 197:25 19:25; 22:20; 27:4;74:11; controversy 42: 10; 127:9, 17; 134:5, 11;
227:5,13,17, 24; 228:2; 88:23, 25; 93:8; 142:9, 17; 13615 135:18; 138:14; 147:24;
conditions 11:3; 97:9;
230:21; 231:9; 236:1, 4; 149:22; 15018; 167:22;
162: 17; 250:2 152:16, 19; 153:24; 160:1; convenience 87:3;
239: 13; 240:4,7, 16; 172:6; 175:1,7; 176:9;
conduct 98:8; 103:2; 165:7,9,17, 18; 167:1; 146:11; 258:5
241:14, 17; 246:19; 177:7; 208:21; 222:24;
107:2; 121:15 182:8; 192:2; 193:3; convenient 146:17
253:17; 268:14, 15; 236:18; 289:6; 290:18
216:14; 218:14; 240:23, conventional 243:24
288: 10; 290:3 conducted 19:8; 142:12, cover 194:20
25; 262:24; 276:10
composition 189:19 14; 160:19 converged 21:12
consistently 23: 14; covered 28:21;
67:9
compound 158:15; conducting zol:7 conversations 149:16
251:22; 255:10 covering 28:4
184:2; 196:2 Conference 17:17 converted 85:24; 86:10
Consortium 199:9,10, kX 154:8; 225:15
compounds 179:25; confidence 52:13,15, 18, 25; 20@4, 7,18, 20; conveys 183:1 Cox-adjusted 153:17
180:3; 194:23; 196:25; 16, 17; 53:22; 54:4, 7; convince 135:2
201:1,9 weate 7:2; 65:4
198:22 67:13; 68:16,17, 20;
constantly 248:19 convinced 26: 11; 40: 1; sreated 39:21
comprises 185:6 70:24; 71:2; 88:17; 91:4
constitute 6:25 92:7; 246:9; 250:20;
confident 103:6 CRI 6:20
compulsion 130:20 258:1,11, 14; 265:3;
confirm 57:1; 117:22; constituted 108:10 Briteria 25:5,5,14, 15;
computer 96:6; 107:18 277:9; 281:16
156:10; 189:1,4,5 constitutes 143:6; 52:21; 97:6; 136:7, 9;
conceivable 255:21 convinceness 237:1
210:11 162:20; 164:17; 188:16;
confirmation 20:2; convinces 276:20
conceivably 44:24; construct 154:17 206:3 ;275:11
161:7,8
232:14 convincing 222:16 criterion 189:6
confirmatory 137:22; consult 130:1
conceiving 31:7 240:4; 244:23; 253:15;
140:23; 208:9 consultant 199:16 critical198:17; 266:22;
282:2
concentrated 90: 12; consulted 8:18 272:16
confirmed 132:25; convoluted 276:23
200:5; 265:11 cross 249:4
138:20; 142:3, 8; 150:21 Consumer 4:14
concentrating 126:2 coordinating 6:20; 105:7
confirming 27:6 consumption 182:24 cross-section 80:4
concentration 85:22; copies 163:21; 170:5
confirms 13:7; 69:15 containing 13:23; 95:24; CRP 93:15
86:19 COf.ly6:11; 169:18,25
conflict 5:20,22, 24; 6:1, 263:16 CRPS 94:4
concentrations 27:22 coronary 264:25
7; 7:3; 19:2,3 contains 167:10; 259:21; crucial 224:2, 20; 230: 18;
concept 80:22; 237:23 corrected 113:19; 232:12 ;239:11
conflicting 30:9 260:20; 263:10; 264:2
conceptual 118:6 250:13; 284:17
confuse 269:21, 25; contemplated 97:14 crux 276:3
conceptually 287:22 correcting 120:21
273:20; 286:4; 291:7 content 193:20 crystal-clear 121:3;
concern 7:6; 44: 11; correction 112: 16; 228:18
confused 39: 1; 160:5; contention 187:3
105:22; 132:17; 133:24; 113:14 ;114:1; 118:7,11;
16%3; 251:13; 259:24; context 20:22; 71: 13; CT 134:6; 135:19; 162:15,
153:16; 154:22; 234:18; 119:6,8, 20; 144:25;
280:25 173:17; 288:20 18; 163:23; 176:17;
235:6; 253:2; 274:13, 16; 145:1,12, 20; 147:7;
confusing 166: 18; 278:7; 188:24; 189:4, 5,8;
275:23; 276:2; 283:21 continents 29:11 228:21,22
287:3 255:10; 256:16,22, 24;
concerned 41: 18; 44:7; continue 70:20; 78:23; corrections 113:9; 257:3
confusion 124:25 98:19; 101:8; lo2:3; 146:25; 223:14; 276:5
84:11; 102:15, 21; 105:16; CUff 138:9
111:9,9,11 ;164:2; Congestive 24: 18; 25:2 108:10; 117:20; 132:16; correctly 71:25; 106:5
ConMad 154:18 147:12; 193:14 cultural 28:14
174:15; 259:18; 274:5.9, correlate 114:20
10,21, 23; 284:3; 288:24 Consensus 17:17; continued 58:23; 123:15; cultured 81:8
correlated 229:14
concerning 7:9; 52Y3; 197:6; 275:1 124:3; 137:!3;15?:1; cUriOUS 127:3; 138:22;
correlates 40:2 139:14
60:5; 82:24 consequence 109: 15; 170:15
cost 49:13, 15;65:10 current 7:16; 17:3, 19;
concerns 18:8; 53: 15; 123:17 continuing 126:23
COStS49:16, 18; 197:9 48:24; 49:6, 13; 92:11
179:14; 190:5; 192:8; consequences 202:15 contradict 262:17
252:20; 253:1; 291:5; couldn’t 72:11; 144:3; currently 31:9; 58:22;
conservative 112:10, contrast 82:21; 83:2
292:10 264:7; 271:15; 289:11 65:19;6&22
24; 147:1 contribute 26:10; 90: 10;
conclude 17:11; 147: 1; coumedin 204:25 curve 21:9; 156:15;
consider 15:16, 20; 20: 1; 146:13, 23; 154:16;
157:7; 287:24 28:20; 119:8; 121:15, 22; 224:18 Council 197:3; 200:25 216:19
concluded 107:24; 122:1; 137:8; 154:8; contributed 12:24; counted 249:2 curves 21:9, 12; 157:23,
108:8; 122:20; 123:4 209:6, 12; 218:2 214:13, 14; 225:12; counting 77:3,20, 23; 23; 215:20
concludes 209:15 considerable 266:18 235:13 289:16 cut 134:24; 215:8
concluding 17:10 considerably 49: 10; contributes 70:13 countries 14:21; %:2; cuts 105:20

Miller Reporting Company, Inc. Min-u-script@ (7) composite - cuts


Advisory Committee Food and Drug Administration
VOL 1, April 28, 19% Peripheral & Central Nervous System

cutting 180:18 Dave 113:8 23; 260:1,4,9,12,14, 19; defines 136:10; 199:19 97:13, 13; 102:2; 107:13;
CVA 188:24; 189:1,5 David 4:17; 16:ll 261:19 ;263:13, 15, 20; defining 161:19; 232:8 108:21, 21; 142:23,24;
XJe 86:8 day 26:20, 24; 27:1; 267: 13; 268:6,9,10,12, definitely 36:12; 159:10; 143:19, 23; 144:12,13,24,
.- 16; 269:24; 270:4,6, 15; 24; 145:4; 149:22; 160:20;
tC 89:23; 90:3,5,7,9 34:25, 25; 35:3, 3; 36:10; 171:11 ;272:21
271:2,21, 22; 272:8; 189: 14; 222:20, 24;
cyclooxygenase 14:6; 37:23; 38:2; 39:6, 23; 40:3; definition 101:7; 122:7;
273:5; 274:4; 275:4, 6; 23725; 238:22; 239:4;
26:7; 27:2; 32:4;35:16, 22; 42: 13; 58:22; 59:5; 71 :8; 162:1;211:5; 246:6; 263:9
276:25
83: 11; 94:7, 8; 95:7; 27612,17, 19,21; 277:11;
36:16; 85:10; 87:17 definitions 24:14;
135:20; 159:!3 168:16; 278:7,13,19, 22; 279:1,4, designated 109:23;
Cyken 37:20 134:12; 136: 13; 162:20;
175:21 ;202:11;208:13; 20,20, 21; 280:2,19, 24; 134:17; 150:2
163:24; 164:17; 188:6
cynicism 250:19; 251:10 222:24, 25; 230:9; 234:12; 281:18; 282:17, 23; 283:2,
definitively 33:8; 43:24 designation 138:17
235:22; 253:1; 265:1; 5, 23; 285:2,5,22, 24;
degradation 90:8 designed 13:13, 18;
D 276: 13; 281:14
days 24:21,24, 25; 26:9;
286:3,12, 25; 287:2,3,5,
7,8, 17; 288:15, 16; 289:2, dagrade 90:5
20:13; 22:3; 44:23; 72:13;
76:21; 94:25; 109:14;
38:9; 134:14,17, 22; 3, 23; 290:23, 25; 291: 17; degree 31:18; 115:2;
120:4; 141:24; 147:14;
D99:24; 104:13; 110:5; 137:8; 170: 14; 186:6; 292:4,19,25 136:15; 154:5; 188:1;
148:3; 206:1 1; 228:16;
114:16, 18; 115:5,7 195:18,25 death-and 74:23 242:23;
278:19
232:14; 247:19
daily 9:18; 26:6; 65:22; deed 77:23; 167:20; deaths 15:3; 21:13; delayed 238:21; 279:2
designing 39:20; 45:7;
83:12, 13; 87:4; 166:10; 168:1; 172:10 22:20; 25:17, 22; 46:5, 14; delays 276:20 238:5
193:4; 201:18; 204:12, 16; deal 69:12; 102:10; 73:5; 75:18; 76:21,23, 23; deliberate 256:18
209:8 desirable 206:3
103:14; 140:15; 168:22; 77:11,13;98:20;100:19; deliberated 246:5;
damage 197:12; 198: 12; 236:1; 251:2; 288:17; 104:8;115:6,6,7,7; desire 112:13
257:24
257:17 290:6; 291:12 140:19,19;169:3,4,12; desired 14:3; 204:21;
deliberation 5:16; 262:9
damaging 33:5; 43:5 dealing 164:13; 229:9; 170:22,25;172:13,16, 23; 252:1 1; 254:1,5,8;
deliberations 7:9; 277: 10; 279:1 1; 283:5;
dance 73:7 232:18; 233:6, 7; 245:4; 173:2,3,11;175:11;
203:16 287:16
256:24 ;283:11 185:22;186:3,4,7,8;
dancing 10S:1I delineated 180:1
deals 115:15 231:11;235:10;241:3,5; despite 25:1; 42:2, 19;
dandruff 75:2 deliver 267:17 201:15; 276:18; 292:10
dealt 56:1; 90:17; 235:4; 242:3,5,8,10;285:15;
data 8:16; 10:24; 12:24; 289:18 deltas 131:3 detail 19:18; 58:15; 81:7;
247:14; 288:2; 291:21
19:16; 22:2, 20; 23:13; DeMets 113:8,24 84:23; 142:12; 229:11
death 10:20; 11:19, 24; debate 113:23;119:17;
27:4, 8; 28:11,13, 17; 131:17; 248:24; 292:18 demographic 142:5;
12:4; 15:15; 18:10,15,17, detailed 10:23; 84:12;
29:1,2,12,24 ;31:18,21, 182:20; 186:25
22; 19:17, 21; 20:6,12,13,
debates 117:15; 158:24 135:14 ;225:21
21; 32:7; 34:13; 36:19, 25;
16; 21:1922:8,9,13,14, debating 248:19; 274:10 demonstrate 14:25; details 85:11
~, 14,15, 17;40:2;
-- 15, 17;23:1, 5, 19,22; debris 47:19 79: 18; 87:6; 92:23; detect 67:17; 233:3;
44:6; 50:1 5; 51:9, 12;
24:2,4,10,13, 21,24; 160:20; 205:3,10 238:18
i; 53:21; 54:8; 55:9; decade 50:11
25:3,13, 16; 37:2; 42:3; demonstrated 183: 11;
56:5, 6; 57:18; 61:6, 19; decades 49:1o detected 81:11; 82:4,17
45:15, 18; 46:9,12, 13; 202:6 ;221:11;28710
62:25; 63:13; 64:5,6, 22; determinant 173:22
decide 98:18; 101:8;
48:20; 49:25; 50:5; 51:1 1;
65:13; 67:5, 7; 68:24; demonstrates 14:23;
102:2; 244:3; 290:11
55:8, 17; 59:19; 60:1; 61:3; determinations 137:13
69:14 ;70:1;71:24; 74:10; 80:5; 187:1
63:9; 66:21 ;71:23; 72:1,8,
decided 19:9; 69:23; determine 24:1; 66:4;
75:6; 84:15 ;87:5; 91:11, demonstration 108: 17;
11,20, 21;93:3, 21;94:12; 9,13, 14; 73:6,8,10,13, 246:5; 276:3 99:25; 101:3, 14; 255:10
201:2; 204:2; 205:24,25
19,23, 24; 74:3, 10; 75:8,
deciding 259:11 determined 6:4; 7:3;
98:3,12, 19;102:25; Dena 194:5,9
12,15, 20; 76:1, 13; 95:3, 27:20
108:7; 110:17, 20;112:18; decision 24:19; 97:24;
denominator 231:3;
113:3, 15;116:14; 117:18; 7, 10; 100:7; 103:17,17, 101:1; 102:19,20,23, 25; devastating 11:2; 48:18;
24; 104:14; 105:16, 24; 289:17,17
120:5; 123:21; 127:18; 127:7,8 ;138:15;221:18, 195:11; 197:9,24
129:14,20, 22;130:23, 24; 115:4; 124:19; 125:4; 20;232:18; 245:25 denominator-so 231:3
develop 42:19; 198:2
128:2,4,5,8, 14,21,22; depend 240:9; 241:18
134:6, 8,9;135:18, 18; decisions 44:8; 97:22; developed 134:20
136:2; 137:14, 18;138:22, 129:10; 130:16; 131:14; 107:1, 3; 127:5; 249:24 depended 136:12
133:3; 134:2,15, 18,21; developing 201 :13;
25;139:1, 18;151:9; declare 167:23 dependent 35:16; 89:6,
137:19; 140:10,11,16,19, 234:6
154:18;
160:22;164:22; 24; 90:4
21,22;141:19;150:13,14, decode 114:23 development 10:25;
165:23;
166:23,23,25; depending 137:18;
20;151:15,18;155:24; decouple 236:3 26:4; 30: 19; 79: 12; 86:23;
173:5;
174:2;177:16,17; 232:16
157:7,16,20;158:23; decrease 202:14; 217:6; 191:12; 195:2; 197:5;
180:6,9,18;183:6;
159:13,20;161:15,18,19,251:1 depends 251:2 198:22; 201:25; 265:11
186:11;187:1;190:12;
20;164:19,19;165:3,5, depicted 85:21 deviation 130:13
191:16,19;193:21;
13,14,16,21;166:4,6,7, decreased 212:14; 283:5 depicts 151:23 devised 253:2
206:23;209:20;214:1,16;
24;168:7,8,10,21;169:7, dedicate 195:25
215:17;221:18,25; depth 240:13 devising 22:23
10,15;170:17;171:2,13, dedicated 199:11
225:24;243:6,6;254:21; derhre 286:19 davoid 265:22
19;173:14,21;174:16,
20; deep 141:14; 155:19
259:14;260:10;262:20;
175:15,19;186:5;190:15; defer 18:7; 234:22 derived 81:8; 190:8 devoted 117:15
265:16,23;271:1,5;
197:16;199:23;204:18; describe 141:23; 193:10 devotes 194:13
273:6,15,15;275:2,3; deficit 136:16, 19; 188:9,
208:23,24;211:8,12,15, described 18:9; 94:3; diabetes 29: 18; 182: 19;
276:6,11,20;278:15,24, 13
18,22;212:3;21616; 188:6; 236:20 197:22 ;200:12
25;280:4;284:10;285:10,
217:4,8,12,20,25;218:1, deficits 47:8; 49:6;
15,20;286:6,7,19,24; 140:24 describing 205:24 diabetics 45:16
4;226:4,11,13;227:6,12,
K-’ 3;289:23; 290:5,6, define 128:5; 137:23; description 176:10,11, diagnosed 249:14;
25;228:3,11;230:14;
,292:5 23 251:15,15
234:2;236:17;238:2,3,8, 161:18,20
data-there 112:15 9,13;241:13;242:2; descriptive 176:20; diagnoses 21:19; 140:4;
defined 128:9; 136:16;
database 20:2 244:20;245:4;250:2,4,4, 139:16; 186:5; 188:15; 177:5 141:8; 162:16; 250:21,23
date 128:25; 176:12; 9,10;253:6,18,23;254:4, 198:9; 205:9; 220:6, 16; dasign 12:16; 13:8; diagnosing 200:20;
188:23 15;257:9;259:18,19,21, 249:17; 255:8, 17; 263:25 14:18:77:1:94:22:95:23:
,-, -—-, 274:23

cutting - diagnosing (8) Min-u-scriptc!i) Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
peripheral & Central Nervous System VOL 1, April 28, 1998

diagnosis 139:12; 141:1; 13; 31:2; 75:4; 125:19; 196:13


;199:2,7 dissolution 48:14 17,24, 25; 57:6, 24; 58:1 1;
162:19; 164:6; 176:17 167:15; 229:24; 277:14; disabilities 49:8 dissolve 38:23 62:22; 63:20; 64:16, 17;
187:19; 188:21; 209:5; 292:21 disability 48:19; 50:8; distinct 156:1, 10; 161:6 81:24; 84:5, 5; 87:16;
246:22; 247: 15; 248:20; difficulties 76:20 197:17 92:23; 175:15, 20; 253:4;
distinction 224:16
249:16; 250:14; 251:22; difficulty 91:6 258:19; 264:25; 266:1
disabled 174:17 distinctly 13:19; 14:11
274:16 dosing 12:20; 14:2, 5;
dilemma 167:9, 13; disabling 174:15 distributed 144:6
diagnostic 25:5 168:19; 270:7 87:2,19; 204:16
disadvantage 258:6,10 distribution 174:4
diagram 47:22 diluted 159:14, 14; 166:4 double 72:6; 112: lq
disadvantages 60:2; disturbance 188:8,12 218:7; 276:24
diarrhea 60: 13; 183: 18; diluting 157:18 61:5 disturbances 97:7
214:14 double-blind 14:17;
diminish 225:25 disagree 33:14; 117:13;
Dick 268:7; 271:24; diverse 80:18; 199:10 81:19; 95:22
diminished 197:25 140: 18; 246:7
281:25 divided 49:16; 136:13; doubled 13:1; 113:1
diphosphate 85:16 disagree-l 260:5
dictating 245:3 21610 doubling 86:18
dipyridamole 10:19; disagreed 247:15
dicumsrol 208:17 12:4,6,12, 17; 13:1,5,9, Division 4:20,22, 24; doubt 36:1~ 224:3
Disagreement 247:7; 7:25; 8:2, 5,8,13,15,18,
die 20:14; 21:18,20; 25; 14:2,4, 24; 27:11,12, doubtful 248:13
248:2 18; 9:17, 20; 203:14,21
23:15, 17; 49:3, 4; 50:5; 13; 51:6; 53:13; 65:25; doubts 93:17
66:15; 67:5,6, 24;68:4, disagreements 248:6,8, dizziness 182:4
77:21; 168:10; 175:7; down 24:23; 39:6; 49:15;
10, 22; 69:6; 70:5,6,8,8, 16; 250:1,3
195:6; 197:14; 231:6; do-but 112:16 94:16; 126:10; 129:8;
239:5 13, 18;71:11, 15;72:17; disappear 5:16 140:7; 151:17; 152:1;
Doctors 173:7
died 22:25; 23:1, 1;24:25; 79:16,20, 23; 81 :23; 82:8, disclose 6:15, 18;199:14
document 224:7, 8; 185:12 ;190:16;215:8;
13, 22; 83:1,13, 24; 84:6, discontinuation 181:25; 275:23; 284:17
134:22; 140:9; 151:2; 243:17
11,20;86:2,12,17,24, 186:6 dozens 201:1
161:22; 167:18, 18;168:2; dominant 150:7
25;87:8,12,18, 25;88:13; discontinue 120:12;
170:13,15, 16;211:23; DP 25:24; 26:3; 83:7;
89:4,19, 23;90:7, 11; 121:17 dominate 155:25
212:1,2 ;231:5 215:12, 13, 21;216:5;
91:2,14;92:5; 95:2,9; Don 169:23
Diener 16:21 discontinued 109:16; 218:25, 25; 258:19
109:3;119:15, 23;143:3,
182:1 Donald 16:9 DPIASA 218:9
dies 75:14; 173:22; 5,7,21;144:1,6,10,14,
233:22 14;146:4,7, 15;147:16, discourage 130:19 done 31:9; 33:17; 45:10; DR 4:3,6,8,10,12,15,
diet 201:19 18,22; 148:18,24;149:8, discovered 225:23 57:14; 58:3; 62:12; 75:16; 17,19,20,22, 24; 5:1, 23;
9,12,2 5;151:6; 152:6,13; discrepancy 88:17 77:4; 107:22, 22; 111:2, 6:15, 18; 7:5,8,19,20, 22;
difference 26:21; 29:4; 12;115:5; 123:5; 125:3;
153:2,11;154:4; 155:21; discrepant 88:22 &7, 12,15, 17,22 ;9:1, 1,
31:21 ;32:23;33:1; 34:9, 133:14; 134:7,10, 10;
12; 53:10, 14; 54:22, 25; 156:18, 22;157:25; 158:7, discrete 145:5 2,5,5,5,13, 14; 10:1,2,3,
13;159:1; 160:11; 166:14; 148:1; 153:19; 163:9,13, 4,9,9,9, 9; 16:9,11,13,
55:22, 24; 58:7, 8; 67:17;
70:15; 88:18; 99:6; 100:2; 179:24; 180:22, 25;181:4, discuss 150:13; 177:25; 23,24;207:17;208:1; 16,17,21; 17:2,5,14,19,
19;182:3, 6;183:19; 209:12; 242:25; 243:6; 225:18;239:14;240:24; 23,23;18:1,3,5, 5;19:2,
106:2; 107:16; 108:18, 19; 265:13; 267:15 251:21;275:21,22;278:4;
110:6, 7; 170:19; 171:20; 184:8;186:14; 189:14; 2,17,19,23;20:3,5,9,11,
192:3,16,22; 2 04:11,13, discussed 80:20; 92:10; 282:20;289:4 17,20,23, 25;21:18,21,
184:17; 185:19, 24;
21;208:3, 12;210:8; 123:7; 184:21; 218:13; doppler 176:18 22,24;22:21,21, 22;
210:25; 214:5; 216:9;
212:22; 213:7,19)20, 2 1; 225:23 dosage 20:8; 58: 19; 23:25;24:6,7, 11;25:6,7,
231:23; 233:4,5, 10;
247:6; 251:3 214:18,22; 215:13; 216:1, discussing 25:24; 45:12; 205:6 B,9,19,23, 23;26:4,14,
11,17;217:11; 218:20,21;53:15; 58:15; 64:1; 229:6; dosages 58:18 17;27:11,13,15,23, 25;
differences 21:9; 29:9,
223:1,4,8, 9;224:20,22; 249:1,2 28:3,3,4,18;29:8,12, 25;
10; 30:24; 31:14; 35:4; dose 11:21; 12:18; 26:1,
238:25; 243:25; 244:8; discussion 9:24; 28:9; 30:20,21,22;31:2,17, 24;
54:5; 56:14; 66:5; 103:20, 3,12,15, 23; 27:6,9,12,
245:16; 258:3,10;263:19; 32:19; 95:17; 151:8; 32:3,7,10,13,15,17,19,
23; 104:6; 106:1; 107:3,4, 23; 28:1; 32:18; 33:20,21,
265:3,4;266:1; 280:9; 178:1; 192:24; 217:8; 19,20)21, 22,22;33:14;
8;108:23; 181:24; 183:2, 23;34:1,3,7,8,9,11,11,
286:1,10 230:3; 251:13, 23; 252:2; 34:5,19,19, 23;35:20,20,
10;185:13; 209:4; 225:18 12; 35:6,6,7,7,8,10,11,
dipyridarnole-alone 266:18; 268:20; 274:25; 20,21,25;36:3,4, 5,7,13,
different 13:20; 14:1, 11; 18;36:2,21;37:1, 1,11,
181:1 276:3; 277:17, 24; 278:10, 13,15,23,23, 24;37:4,
29:14,14,22 ;31:11; 12,15,16, 23;38:8,10,
dipyridarnole-aspirin 18; 282:6 10,14,18, 18;38:24,24,
32:16; 34:21; 35:5; 37:11; 11,13,15, 21;39:16,23,
61:21
25,25;39:7,14,17,21,
38:5; 43:15, 25; 44:19; discussions 7:1o; 23,25;40:16; 41:22; 42:3,
23;40:14;41:2, 16,16, 21;
45:3; 51:3,12, 16; 52:24; dipyridamole-related 274:11 13,18,20, 22;53:15, 24;
42:6,9,24, 25;43:1,9;
58:2; 62:20,21,22, 22; 186:16 disease 20:8; 28:12; 54:9; 55:5,14,14,18,18,
44:12,15,24;45:1,4,4, 5,
63:20; 64:14,16, 17; dipyridamole/aspirin 33:2, 2; 48:1, 19; 49:20; 20,20,21, 24;56:2,9,15,
23;57:3, 18;58:8, 22; 9,13,13,14,22,22, 24;
66:10; 79:24; 84:5; 90:3; 63:25; 67:11,20 51:17, 18;61:1; 76:24; 46:2,12,13,14,15,17,
104:10, 14; 106:15; 142:6; 175:23; 182:11,16, 59:1,7,8, 23;63:18,22,
dipvridamola/mL 86:19 22,23,25;47:1, 3;52:13,
119:21; 130:18; 145:12; 16, 19; 195:14; 200:6,12, 24;64:1; 71:7,7,15;
direct 35:12, 25; 36:9; 15;53:16,18;54:14, 15;
154:11 ;165:10,12; 24; 235:5; 239:15; 241:10; 81:22 ;82:12;83:13;
40:13; 49:16: ~5:4; 62:24: 56:1,3,11,11,11,12,16,
167:16; 169:12, 20; &113;261:13,21; 93:17; 154:20, 25;165:6;
65:14; 66:3; 126:16 20,22,24;57:1,4,4,5,9,
189:17; 190:10 ;200:21; 264:25; 276:18 175:14, 22;193:4; 209:8,
directed 148:3; 187:2 20,20,21; 58:2,10, 12;
219:10; 222:5, 6; 225:17; disease-related 186:25 9,10;253:3; 258:6,17, 23;
62:11,14,17, 18;63:18,
230:9; 231:19; 232:18; direction 91:20; 116:17, 259:25; 261:22,23, 24;
diseases11:11;
32:24; 20,22,24;64:2,4,6,16,
235:2; 245:5; 250:1; 18; 163:8; 239:16,16, 21; 264:23; 265:3,21,22, 23;
51:16
;98:16 17,19,20, 24;65:2,6,12,
251:19; 256:7; 258:19, 23; 240:19 275:1
disentangle 236:2 16;67:2,3,3,4,4,8, 23;
259:3, 3; 269:22; 271:9, directions 121:16 doss/high 55:21 68:1,3,5,9, 12;69:7,7,8,
11;273:12; 275:19; dishonest-1 290:21
directly 5:18; 33:22, 22; dosed 204:11 8,9,18,19,20, 24;70:3,3,
284:18 80:23; 132:22; 161:3; disk 188:25
doses 13:19; 26:19; 5,20,21;71:22, 24;72:12,
differently 29:23; 31:1 5; 286:18 disorders 181:3,5 33:23; 34:15,15,16,16, 15,21,22,23, 23,24;
52:22; 232:22; 233:20 Director 6:18; 8:13; disrupt 20:22 21,21 ;35:14,23;39:5; 74:7,7,8,12, 21;75:1, 2,
difficult 23:6, 23; 25:10, 16:16; 17:15; 18:4; disruption 47:5 40:8,10, 17; 41:4; 53:17, 11,24, 25;76:3,7,9,10,

Miller Reporting Company, Inc. Min-u-script@ (9) diagnosk - DR


Advisory Committee Food and Drug Administration
‘VOL 1, April 28, 1!)!)8 Peripheral & Central Nenous System
.— —
15,15,16;77:7,7,8, 16, 24; 172:19, 19; 173:18,18, 289:4,10, 10,11,11,19, duration 154:20; 176:12; 130:12;132:14; 134:25;
25;78:2,8, 13,15,15,16, 19; 174:10,13,21,21, 22; 22,22, 25;290:5; 291:1,1, 190:21 143:1,7,12;145:23;
17,21,22,23, 25;79:3, 3, 175:14,16,16, 17; 176:1, 3,9,9, 10;292:7,9,22 Durham 199:3,7 146:13;147:15; 155:15,
~+7, 11,13;80:20; 83:4, 1,3,5,7,20, 24; 177:3,5, DRACHMAN 4:17, 17; during 50:3; 60:11; 20;157:4,19,20;158:20;
7,8,9,11,15,17; 6,8,11,15,17, 19;179:3, 20:5,11 ;21:18;35:20,21; 106:24; 107:1, 5;175:7; 159:8,12,15,19,22, 24;
8zx4,7;87:2;88:4,7,8,9, 4,5,7,181:9,12,14, 15; 36:3; 45:13, 14; 56:11; 176:9; 210:7; 212:7; 161:15;164:7;165:14,15,
24;89:1,3,17,17,18, 20; 187:4,8,10,14,15,16, 57:4, 5; 83:15; 89:17, 18; 213:1; 222:24 21;1=23; 167:11,17, 25;
90:14,19,22,22,23, 23; 17;18924;190:1; 191:6; 90:14; 105:9; lo8:13; Dutch 34:7; 54:20; 56:10, 169:14;171:1,6; 172:16;
91:22,23,24;92:10; 93:1, 193:17,17,20,22, 23; 114:2,3, 13; 123:20, 21; 12 173:11,20;174:4; 175:21,
4,9,11, 14;94:4,6,14,14,1%:8,11,11,12, 13; 129:17, 18; 140:1, 2; 24;181:19;212:15;
dying 24:20; 134:14, 16;
17,18,21;95:16; 97:15, 198:25, 25;199:4, 4; 164:19; 175:14; 220:14; 223:22;224:10, 11,12;
175:2, 3; 200:17
17,18,20, 25;98:4,6,6,9,202:24, 24;203:3,6,9,17,241:2,3,21 ;249:11,12; 228:12;229:17;233:12;
dysfunction 90:17;
12,20,22,23,24, 25; 18;207:4, 22;209:17,19, 251:14 ;254:1,4;255:1,6; 234:25;237:1;238:6,8,
198:13
99:1,5,9,18,20,21,22,19,22;214:25; 215:4,6, 256:3; 257:4,13, 19; 19,19,20;239:24; 240:11,
25;100:2,4,6,10,12,15, 10;218:13; 219:5,6,7,11,268:2; 279:13,14, 25; 11;241:15,16;244:20;
17,17, 19;101:3,5,7,14, 12,14,15,17,21,23, 25; 280:10; 281:24; 283:13 E 246:11;258:2;260:11;
16,18,19,19,20,20,21,220:4,5,14,16,18,21, Drachmsn’s 46:2 263:19;264:8;266:19;
24,25;102:4,8,9,18, 20; 25;221:3,9,13,15,19, dramatic 50:19; 242:15; 269:12;270:4,6;271:20;
each 15:6; 16:4; 49:2, 14;
103:1,10,15,15, 16; 20,21,22,24, 25;222:1, 261:4,7 274:1,3;275:6;276:8,12;
61:25; 81:10, 24;82:9;
104:1,1,4,5,7,10,18,21, 2,4,21, 22;223:3, 5,20, 278:23;283:25;284:1,2;
dramatically 66:10 95:24; 114:18; 143:3, 11;
24;105:3,4,8,8,8, 10; 25,25;224:1;225:8,9,9, 145:14; 146:13, 22; 147:5, 285:11,23;286:25;
draw 66:14; 157:1; 160:2
106:20,22, 23;107:10; 10,14,14, 15;226:2,6,6, 9; 148:12; 149:24; 152:20; 287:17;288:10,11,14, 16;
108:13,13, 14;109:1, 19, 7,10,14,17,19,20,21, drawing 80:5; 237:2 289:24;290:17;291:22;
153:4; 177:12; 185:8;
19,20,20, 21;110:2,5, 25;227:1,4,9,10,11,14,draws 149:8 190:24; 195:5; 197:13; 292:11
12;111:14,15,16; 112:3, 15,18,20,21, 25;228:5, drew 191:2 201:12 ;205:5,6,11; effective18:21; 19:21;
6,7,8,22,24;113:7; 6,6,7;229:1,1,2,2, 10; driven 43:12; 148:17; 206:7, 19; 210: 11; 223:7; 26:12;51:4;
53:11; 55:25;
114:2,2,3,11,12,13,15, 230:1, 3;233:17,18, 19; 240:17 224:3; 225:4; 237:1; 59:18,25;61:3;66:1,16,
17;115:4,10,11,14,17, 235:1, 15,20; 236:11,11, drives 219:1 246:2; 251:16; 272:11; 20,24;160:10;194:23;
18,18, 19;116:8,11,19, 12,23;237:17,19, 23; 287:15, 23; 288:5; 289:6 1%:3;198:14, 18;205:7;
driving 284:11
20,21;117:6,7,8,8,13, 239:1, 12;240:1, 9;241:2, earlier 32:17; 43:2; 54:12; 219:1;
221:8;223:2,2,7,
24,24;118:1,17, 22; 2,3,9,21, 23;242:12, 24; Drs 6:10; 17:8,24
68:13; 89:8; 134:14; 9;224:9,19,19,21;
119:9,10,25, 25;120:1,6, 243:3,5,8,11,12,16,16, Drug 4:25; 6:5; 7:25; 8:8; 253:16;268:13;292:23
148:7; 152: 17; 153:8;
7,8,23;121:9,13,19, 21; 17;245:2,7,10,12,23, 10:5, 15; 18:1; 45:21;
157:1 1; 158:20; 163:18;
effectively 154:3
24;246:15, 15;247:2,7,8, 58:22; 59:13; 60:1o, 23; 203:23; 204:5; 206:5;
=Pi~ ~~~~~~1~’ ~7i2 24,24;248:7,10,10,12, 73:2; 74: 14; 88:16, 22; effectiveness 132:1 1;
211:11 ;214:19;224:8;
160:21, 23; 203:25; 204:2;
. ,18;20: 21,24’;
1’2;:11; 18,21,23, 24;249:1,5,7, 90:15, 16; 114:8, 14; 231:10; 233:23; 276:12;
13,14,18, 21,22;126:18, 8,9,11,12, 19;250:3,6,7, 121:4; 134:25; 144:10; 205:3, 25; 207:3,12, 16;
278:18,21 252:8,10, 13; 262:21;
18,19;127:4,7,10,11, 8,9,17,17, 18;251:11, 148:5; 157:2; 164:6,8, 11;
167:17, 25; 173:20; 174:3; early 50:6; 67:6; 89:7;
270:13; 277:10; 279:11;
12,15,16,16,20,23,23,11,12,14, 24;252:3;
121:18 ;173:1;241:25
280:17
24;128:3,4,7,9,10,12, 253:25; 254:1,3,4,7,8, 175:8, 9; 177:25; 178:2;
15,17,18,19,20,21,22,11,12,14, 24;255:1,3,6, 179:10; 182:11; 195:23; easier 107:7; 243:21;
effects 12:20; 13:10;
23;129:1,3,5,17,17,18, 8,13,14,15,23, 24; 203:5; 205:9; 215:11, 15; 277:6,19 19:14; 27:8, 10; 29:10;
22,24;130:1,3,4,5,10, 2563,7,15,16,18,20, 221:7; 223:21,22, 23; easily 139:6; 33:16; 34:23; 35:1,14, 23;
184:18
14,22;131:16,16,17,21,23;257:1,4,7,7,8,12,13, 224:9; 234:4,16,17, 25; 36:1, 3,9; 38:4, 16; 40:11,
Easton 16:10; 45:22,24;
22,23,24, 25;132:7,15, 15,19,21, 25;258:16,20, 235:18; 246:11; 249:3; 11;41:8, 15,25 ;42:12, 18,
46:13, 15; 56:20; 57: 1;
16,17;133:9,10,11, 17, 21;260:7,15, 16;261:1,1, 257:22; 258:4, 8; 259:21, 23;60:9, 12, 14;65:10;
78:15, 16; 90:22, 23;
17,21;134:23; 135:1,2, 2;262:7,11, 12;263:2,2, 24;260:1; 261:11,25; 80:23; 81 :18; 89:5; 92:6;
116:19, 21; 117:8; 163:1;
13,20,24,25, 25;136:4, 3;264:5,5,6,11,14,15, 270:5; 274:2; 275:19; 164:1; 169:18; 95:11 ;98:14; 99:12;
170:4
6,12,18,21,22, 25; 15,16;265:10,15, 25; 279: 17; 280:5, 6; 285:18, 123:8; 124:6; 126:3;
easy23:22; 102:9; 160:5;
137:3,5,6,9,11,12,13,266:4,7,8,13,13, 14; 20; 286:9; 287:7; 288:3; 142:19, 25; 143:2; 144:1;
232:24
16,21;138:1,3,5,6,9,10, 267:3,5,10,15,19,20, 290:11, 13; 291:16, 23; 145:24; 146:1; 152:19;
292:23 ECGS 134:9,10 155:18; 156:22; 158:5;
14,16,19, 20,25;139:1, 21;268:1,2,3,8,9,10,12,
3,14,18,19,22,24, 25; 14,15,19,22, 25;269:3, drugdemographics echo 283:17 159:18, 21; 161:7; 183:11;
140:1,1,2,6,6,7,14,14, 4,5,7,8,10,13,15,16, 182:11 echocardiograms 192:2 ;205:6;214:11;
15;141:3,3,6;143:15,15, 17,22;270:1,1,2,3,9,11,drugdisease 182:14 134:10 241:12; 263:1
17,18,25;144:5,8,13, 12,18,19,23, 25;271:9, drugs 25:25; 62:13; economic 49:12 efficacy 11:10; 13:4, 13;
16,18,20,21;145:21; 10,11,19,20,22,24; EDIF 90:6 17:8; 28:12; 34:5,12, 21;
73:22; 95:11; 143:12;
146:8,8,9;147:10,12; 272:2,5,10,14,15,16, 145:6; 154:9, 15; 205:25; educate 200:7 35:18; 37:8; 51:1O, 19;
148:19;149:5,17,18,19,23;273:1,3,8,13, 21,25; 258:12; 262:4; 27G; 54:22, 25; 55:19; 60:23;
education 195: 19;
20;151:8;154:8,12,14, 274:6, 7;276:13;277:5,5, 275:14; 285:1,3, 17; 61:19; 64:9, 12;65:9; 66:4;
199:12; 200:23; 201:3,7
17,22;155:3,6,9;159:7, 6,15,17,20, 24;278:2, 88:15; 89:19; 90:16;
287:9; 288:13, 21; 291:16 educational 194:15;
7,10,11,14,19,23; 11,17,21;279:9,13,14, 93:10; 94:19; 95:1,16;
161:10,12,13;162:2,4,6,14,24, 25;280:8,10,11, DSMB 116:25 199:18; 201:5,15 99:17; 100:9; 105:14;
8,8,9;163:1,13,22; 13,15,21;281:3,12,13, due 11:21; 13:8;46:6, 7; effect 18:18; 26:8, 21; 106:8; 108:8; 113:13;
18,21,22,24,25;282:1, 47:9,10,14, 24;48:3; 32:3; 34:1,2, 18;36:10, 114:21, 24; 115:9; 121:18;
~’~; :&;;;~~6;:1’ 4,13,15,19,21,22,25; 49:6; 50:23;76:23, 24; 11;38:4,9, 14;42:14; 126:1, 2; 132:19, 23;
L5;16+:3:5,i4;168:2, 283:7,8,11,13,14,15, 200:11 ;212:1,3;219:10;56:3; 57:17, 25;60:6, 19; 133:7; 141:24; 142:8;
4,6,8,11,12,15;169:18, 17,18, 19;284:24;285:5, 235:11;248:14; 261:9; 66:7, 8;73:6,10,13,19, 156:11; 158:25; 159:2;
20,22,24;170:1,4,8,11,7,9,10,12,14, 16;286:6, 262:9; 288:11 23;74:3, 24;75:15, 20; 160:8, 22; 187:23, 23;
11,20,23,24;171:3,9, 16,24;287:1,2,10,12, Duke 4:19; 6:18, 19,20; 78:5, 6;82:8,22, 25;83:2; 192:6; 196: 18; 202:6;
11,12,15,17,21,22,23,18,21;288:8,8,9, 24; 199:2,6,8 92:3; 93:18; 94:9;112:4; 205:15,21, 25; 208:2;

DRACHMAN - efficacy (10) Min-u-scripts) Miller Reporting Company, Inc.


Food and Drug Admlnktration Advisory Committee
Peripheral & Central Nervous System VOL 1, Aprfl 28, 19!38

209:20,21,
25;211:7,
17; endarterectomy 34:14; 241:12;
242:18;245:5; 238:5 176:25; 182:16,23;
221:11 50:12,
24;55:7,9,
23; 253:5,7,8,
10;261:4,7, Essen 16:21 183:15; 184:9,11,23;
efficient 83:24; 85:9; 154:24 24;275:17,
24;276:2; essentially 59:3; 159: 11; 187:19, 20;188:19,21, 23;
.-=- 189:9,16207:4; 210:3,
86:3; 87:14, 19; 118:14 ended 117:1; 127:21 284:18;
290:3;292:11 216:9 ;230:16;231:1,21;
endpoints-and 172:25 232: 19; 233:3; 246:19; 22,23;211:2 ;213:10, 13,
effort 262:24 endoscopy 36:7
engineered 118:20 274:13 14,17,19, 25;241:7;
efforts 194:20; 195:19; endothelial 80:6; 81:8 249:2,6;250:11
200:5; 201:9, 15; 202:1 endpoint 11:24; 15:22; England 4:10 establish 13:13; 15:4
events14:9; 24:16;
eight 70:21; 71:6; 77:4 18:15, 16; 19:17, 24; Englewood 194:6 established 11:1o;
26:13;38:12, 15;51:24;
either 12:7;
47:11,
16; 21:11; 22:9; 23:9, 11,24; enhance 12:20; 14:3; 8022; 95:10 122:4;
55:25;66:9;80:17;91:6, 7;
48:3;
55:13,14;72:2,19; 24:15,20;54:10;61:2; 1%:25; 202:9 163:15; 165:4; 180:2; 93:13,13;%:19;101:2;
94:7;
97:8;104:13;111:6; 63:2;
72:16, 20;73:3,3,5, Enlighten 227:21 247:20; 248:25 104:19; 114:21,21,24;
117:10;
131:4;171:1; 8,16,23,24;74:4,5,16, enormous 11:7 establishes 193:8 115:9;118:11; 139:17, 20;
208:7,
23;214:17;221:12; 17,22,25;75:12;76:19; establishing 159:24 141:10,11, 18;155:19, 23;
enough 35:15; 39:11;
239:6;
245:18;253:16; 77:11,12,12,23;78:4; estimate 10711;229:16; 167:22; 169:6,8;170:17;
44:25; 47:6; 48:12; 70:17;
254:9,
22;279:22;280:17; 90:25;
91:16; 99:6; 231:1; 232:2, 3;235:7; 172:22; 174:24,25;175:4,
113:12; 172:17; 173:2;
284:16 101:23,25;102:6, 13; 12;176:25; 179:22;180:2,
222:8; 266:24; 270:14; 239:2,3,9
elaborate 229:25 103:13,18;105:14; 112:1; 15;181:22; 182:4;183:17,
277:9; 284:9; 290: 19; esthneted226:17;
115:15;116:12;121:8; 292:6,8
20;184:4,4,6,7,16, 19;
elderly 195:14 242:21
124:19;125:4;128:5,8, 185:3,5, 18;186:13,16,
elements 80:8 enrolled 60:25; 64:15 estknstes48:25; 49:6,
13,14,15,24;130:17; 19,22;188:6, 18;192:19,
elevated 201:23 133:15;134:15;135:22; ensure 24: 14; 120:22; 13;54:2; 276:9 20,21;198:7; 202:8;
eligibility 248:13 137:19;138:21,23,23, 24; 256:16 estimating 235:7 208:17; 214:3,4,6,7,21;
eliminates 192:8 139:16;140:8,9;141:18; ensures 80:12 estimation 190:17 231:13,13, 16;238:20, 21;
150:12,13,15,16; 155:25; entered 175:6; 210:23; et 76:1 239:11; 240:11,12;
eliminating 286:3 241:16,16, 19;274:17
156:10,11,15;157:7; 211:1 ;213:12,14
elimination 86:5; 261 :8; ethical 30: 12; 100:25;
158:4,
6;159:16; 161:25; enteric 38:16, 19 102:12; 130:19; 198:13 tWfAWItUdly118:20;
279:19 163:20;165:2;167:24; 277:25; 290:13
entering 229:8 Ethics 30: 14; 97:21; 98:7,
Ella 4:12 168:20,21,23,24;169:2; entire 14:2; 87:2, 19;
12, 17; 101:10, 12;103:2, every39:22; 40:3;
42:12;
eloquently 40:18 170:14;171:7;175:19; 194:11 65:20;73:21;94:7;
3,5,8, 25;104:15, 23;
else 32:4; 75:3; 161:16; 176:8;184:20,22;190:9; 102:17, 21;114:19;177:8,
entirely 76:1 2; 250:25; 105:1, 22;108:6,6;
166:7; 202:25; 230:5; 207:14;208:21;209:1; 10,12; 190:24;195:6
288:11 110:16, 22;114:4; 127:6;
232:13; 235:11; 236:12; 211:8,17,19;212:22; everybody 39: 10; 74:19;
entirety 70:12 189:20; 238:15,16
-: 237:10; 258:22; 261:18; 216:16;218:1,15;221:12; 84:10; 135:8; 239:3;
___ ethnk 28:14,16,21, 23;
264:19 222:14,16;223:15; 225:6; entity 265:7 249: 13; 276:23; 277:22
226:3,8,13,16,23;227:2, entry 97:5; 164:17; 207:4; 29:5,10,14, 15; 32:16,24 everyone 131:1 1; 195:9;
elsewhere 69:14,25 etiology 176:15
6,13,17,24;228:8,12, 246:17; 247:1, 3; 249:1 261:18
embedded 207:8 15,19;229:4,12,19, 21; Europe 14:21; 28:19,19,
equal 96:17; 181:10; Everything 100:22;
embodies 2&:23 230:11,11,11,21;231:9, 232:20; 291:16 20, 21; 96:3; 103:8; 135:5;
218:17,17,20,23, 25; 151:12; 155:12; 269:25
emboli 11:21; 47:24,24; 18,19;232:11; 233:1;
eqldy 24:17
48:8; 50:22; 257:19 234:1,4,11,14,21,24; 219:3; 221:3; 275:22 evidence 16:4; 29:17;
235:16;236:1,4,21; equivalence 286:18 30:23; 35:25; 36:18;
embolic 47:17 European 12:9, 13; 19:9;
238:2,4,12,17,25; equivalent 140:4; 37:22; 40:5; 41:23, 24;
embolisms 141:14 94:23; %:4; 209:4, 5;
239:22;240:4,7,16, 22; 157:20; 222:8; 280:7; 211:4; 252:9 43:12, 19; 68:25; 69:4,13,
embroiled 276:17 241:14,17;242:4,7, 11, 286:20 25; 70:7; 71 :6;80:20;
evaluate 13:8; 142:25;
emerge 182:8 16;245:3,6;246:10; erectile 90:17 87:21; 90:9; 140:23;
147:15
emerged 43: 19;61:19 247:4,21,23;248:16; error 105:18; 110:1 1; 156:23; 158:8; 160:14;
evaluated 52:10; 64:10, 165:20; 166:14; 175:22;
Emerita 4:12 255:17;260:4,6,11; 132:10; 147:2; 218:3
261:5,13,15,21;268:11; ESP 91:7 11 188:23; 192:5; 203:24;
Emeritus 16:16
277:11;279:4;283:22, 23; Evaluation 6:5; 18:2; 205:16,17, 17; 208:9;
emotional 202:16
285:2,13,22,24;286:12, especially 13:15; 28:23; 133:14 216:18,24 ;217:12,19;
emotionally 195:12 30:17; 41:6; 81:16; 161:6 mren 5:25; 15:7; 20:24; 218:7,11, 15;224:8;
21;287:5,8;288:IQ
emphasize 32:22; 63: 16; 163:10; 201:22 23:11; 33:4; 35:14; 38:16; 237:4,
6;245:22; 252:10,
289:5,15;292:15,18
84:8; 87:10; 147:23; 151:9 endpoints 18:14; 19:1,7, ESPS 15:14; 91:18 39:9; 50:15; 52:11; 66:8; 13;253:16;261:19;
empirical 39:8 8;22:23;39:18;44:6; ESPS-1 12:10, 15; 13:4; 76:13; 99:22; 103:18; 266:23;267:2,4,6,11,12,
empiricism 39:13 62:25;70:17;72:12; 73:1; 67:21 ;88:10, 14;97:13; 104:2, 10; 105:14; 111:20; 22;268:4;269:11,14;
14:23;77:9;78:1,3;92:24; 148:20; 208:11 112:9; 113:22, 25; 124:2; 270:13,14;272:24;273:1,
encompassing 199:19 2,4,12,22;277:10;
103:24;107:8;111:10; ESPS-2 12:14,16, 23; 126:14; 130:12; 134:20;
encourage 194:22; 148:20; 152:17; 161:1,3; 278:14;279:10,12,19,22;
115:8;118:5;126:15; 13:12 ;14:16; 15:11,23;
196:4 167:11 ;171:1,5; 172:10; 280:17;281:1;283:2,4,
128:13,17,18;129:2, 9; 16:19, 22; 19:8,15,20, 24;
encouraging 130:7 130:16,18;132:19, 23; 20:10, 18; 28: 18; 29:17; 195:16; 201:15,20; 10,15;284:7;288:15
end 11:16; 21:10 ;77:18; 133:8;141:7,12;150:12; 30:17; 37:4; 41:23; 46:4; 223:22; 226:21, 23; 229:8, evident 82:11, 24;
82:1; 93:2; 105:17; 155:9,11;156:9;161:6; 56:6; 57:10,11,13,15, 15; 22; 236:20; 241 :7; 242:10; 179:21; 183:2
106:12; 110:11;113:9; 162:10;171:4,15;173:13; 62:8; 63:8; 67:10; 68:24; 249:16; 257:17; 260:21; evil 118:6
115:4 ;130:13; 131:8; 185:15;187:3;190:14, 15; 69:2, 16;70:1, 11,12,25; 263:17; 265:22; 266:25;
:-.-. evolving 188:20
135:20 ;137:14;151:11; 204:4; 207:19,20, 22; 71:6,7,10 ;81:21:83:14; 275:2,6,21 ;27815 ex 192:1
168:16; 216:19;222:25; 208:19; 211:4;217:24; 84:10,15 ;88:15,25; event 7:9; 9:22; 11:2;
230:8; 234:12;235:22; 23:10; 38:6,20; 42:21; exacerbation 84:25
218:2,4;220:6,9;226:11; 95:14; 98:10; 109:1;
274:9; 281:14 227:7,12,19;230:7,15, 155:10:165:8:186:11: 66:12, 17; 93:23; 94:2; exact 56:19; 107:23;
endarterectomies 16;232:8,10,19, 20; lti:l; i92:5, i,10;193:8; 96:9,21, 25; 114:18; 122:7;
292:2
210:6,9 235:10,13;240:15; 206:19; 207:21; 209:4, 23; 117:2.11.11:131:3:
. . . eXaCtlY43:21;
81:20;

Miller Reporting Company, Inc. Min-u-script@ (11) efficient - exaetly


Advisory Committee Food and Drug Administration
VOL 1, Am’il 28, 1998 peripheral & Central Nervou8 System

.83:13; 100:13, 13; 130:10; 195:4; 196:6; 197:11; 99:16; 110:20; 111:16; fibrin-p iateiet 11:21
139:12; 142:13, 14; 239:7; 240:3 F 246:17,18,
25;255:25; fieid 148:20
~7:16; 18;272:25; experienced %:6; 259:18;
274:4 Ffih 252:20
.-
10;289:1 201:16; 210:24 FARRELL 170:11,11, 23; Fifty-fiity 58:12
face73:ll,21; 198:l;
~mination 115:15; experiencing 212:13,15 247:11 203:17;
207:5,
22;209:19,
figure 21:2; 23:22; 61:16;
: 135:7, 10; 136:24; 137:7; 22;221:10
experiment 108:17; faced 647 172:14; 190:24; 228:21;
140:24; 188:22,25 fashion 107:23
115:23; 117:20, 22; faces50:6 248:15, 18; 277:4; 281:15
examine 31:2 fasting 183:8
118:20; 143:1 fact18:21; 19:20;22:3; figured 161:25
examined 21:2; 31:1; fatai 77:2, 19; 171:17;
experimental 90:9 23:6,22 ;24:1;25:1;
41:17; fiiied 48:22; 135:22;
207:3,19 172:9; 174:24; 175:2;
experiments 82:18 61:25 ;71:21;73:13; 177:11;
247:9,10
example 23: 13; 36:1; 210:18; 211:25; 212:9,16;
expert 39:21; 40:1 88:10; 96:21;103:8; finai 11:18; 124:7;
43:9; 73:4; 75:14; 110:6; 221:9; 238:20, 21; 239:6;
105:12;106:6; 107:7; 126:14; 250:14
136:11, 22; 148:10; 149:8; expertise 1%: 18 240:12; 241:16, 19;
110:1; 113:21;114:22; ffnaiized 59:7
172:5; 207:9; 219:18; expertly 240:24 261:14,21 ;284:16
116:6; 122:13,24;125:20;
220:25; 221:3; 234:1; Finaify 15:11,23; 17:14;
experts 16:8; 32:8; 131:11; 145:2;147:20; fataiiy 261:14
243:21; 244:8; 250:1Q 66:13; 79:23; 80:17;
37:17; 245:1 148:9; 162:25;165:23; fsvor43:23; 56:15; till; 87:24; 95:13; 141:17;
264:24; 278:3; 282:24
expiain 19:1; 83:10, 15; 168:24; 192:18;210:18; 67:15; 69:2, 18;91:16; 143:11; 153:22; 156:2;
example-l 224:6
88:17, 21;99:25; 190:19; 223:15, 16;229:11; 215:15 ;261:19;268:22; 160:8; 161:5; 204:7;
Examples 201:4; 274:3 234:20; 236:20;238:21; 269:5; 281:14
231:11; 243:18; 250:6; 207:25; 209:3
exceeded 199:21 26422; 283:20 239:20; 240:12;242:10; favorabie 66:17; 119:1; financimi 6:3; 7:1, 12;
exceeding 180:16 explainable 184:18 251:5; 258:21;260:19; 159:4; 180: 11; 187:7; 199:15 ;202:17
excellent 41:21 261:10;263:7; 272:3; 192:16
expiained 26:4; 147:3; financially 195:12
except 260:23 279:20; 281:16,22; favoring 55:19, 24; 57:3;
187:4; 247:24 find 19:2; 36:8;70:16;
exception 177:8 284:17;285:20; 286:2; 91:2
expiains 86:15; 250:15 287:16;288:9,11,15, 20; 72:10;94:6;163:8;
exceptions 6:8 FDA 4:21,23, 25;7:11; 166:17;172:16;173:3;
explanation 73: 18; 289:23
excess 100:7, 11; 101:2, 11:14; 15:24; 16:3; 19:13; 181:23;182:8;184:12;
74:15, 19; 88:16; 89:12, fact-and 251:4
4,7; 234:5,16,17, 25; 13; 171:25; 174:7; 235:23 21:25; 37:21; 43:1Q 1%:2;205:22; 231:15;
235:18 factor 195:21;198:4; 58:16; 59:3; 129:7; 142:2; 232:17,23;243:21;244:7,
expiicete 110:22 224:25
excessive 80:13; 121:18 160:15; 179:13; 2ol:lq 10;253:3;258:23;265:22;
expiicit 110:23; 125:15; factored 276:19 202: 19; 203:7, 12; 242:12, 275:16;283:1
excited 235:24
254:2 factoriai 12:16; 21 :3; 14; 243:9; 245:8; 251 :24; finding 26:3, 21; 27:23;
exclude 7:13; 162:16;
explicitly 229:7 95:23; 142:18, 23; 143:19, 257:22; 262:14, 23; 28:2; 70:15; 173:1; 186:2;
F-2; 221:18; 270:4,6
exploratory 142:4 23; 144:12,13, 23; 145:4; 265: 14; 273:6; 275:9; 195:25; 238:6, 7; 245:17;
Juded 151:11; 147:14,16, 24; 148:2,15, 277:3, 21; 291:18; 292:7
expiosive 85:3 258:17; 265:21
206:23;
209:24;
221:16 15; 149:3, 7; 152:11; FDA’s 8:16; 71:4; 194:3; findings 18:25; 28:16;
excludes 33:5 exposed 81:9; 275:13 156:21 ;158:3,21; 159:1, 240:21; 291:6 58:18; 119:22; 137:10;
exclusion 7:14; 43:5; exposes 80:7; 109:10 24; 160:20; 181:16; FDA-and 41:2 185:16; 188:3; 192:1, 9;
62:21; 97:6; 189:6 express 87:14 183:14, 16; 189:13; 240:23; 244:22
FDA-approved 15:9;
execution 120:25 expressed 132: 18; 192:13; 207:9; 222:20, 24;
193:4 fine 149:6; 257:12;
Executive 5:21 253:22 236:17,18, 25; 237:14, 17;
features 176:20,22 271:18; 278:10
276:25
exercise 242:14 extend 28: 16; 131:6 Federai 58:17 finger 2!44:19
factors 29:16, 18; 96:8;
exhibit 42:4 extended 71:14 ;79:15; feedback 86:8,12 finish 65:16; 246:3
154:13; 187:1; 197:18,19,
exhibits 154:5 81:22; 82:12; 86:24; 87:3, finished 149:21
24; 198:3; 201:17; 206:14, feei 28:1; 33:3; 61:18;
existed 225:17 7, 18; 95:1,9; 116:23; 18, 19; 210:3; 225:12 74:5; 75:7; 103:61 10:3; finishing 242:12
143:3, 25; 144:5,14, 16; 186:11;
187:5;
228:15;
existing 108:7; 109:17 facts 272:3 firm 7:10, 17; 22:17;
146:4; 151:5; 153:1;
exists 44:19 Fatuity 4:12 235:2;
244:1;
246:13; 66:14
154:3; 186:13; 192:15; 259:4;
271:22;
283:9;
expand 112:14 204:10,22 faiied 170:15 firmiy 249:12
289:20
expanding 112:17; axtended-reiease faiis 109:12,12 firms 6:4
fee[ing
54:4;
167:14;
198:19 10:19; 12:17; 13:24 faiiure 24:18; 25:2; first 9:12; 12:9; 18:25;
253:11;
264:4;
284:22
expect 9:4, 24; 37:6; extension 8:2; 116:15 134:19; 170:17; 182:17; 21:4, 24; 26:6; 29:25;
feeiings 261:3
75:19 ;79:4; 103:3; 131:1; 233:25 36:17, 22; 38: 10; 49:24;
extensively 19:7; 202:4 feeis 75:5
156:5; 166:11; 186:18; fair 91:19; 231: 10; 238:20 50:4; 56:11; 59:12, 14;
187:22;219:8;220:20; extent 110:4; 162:23; Feeney 8:17 60:11 ;70:5;79:18; 88:25;
261:12 ;276:14 fairiy 66:6; 111:19;
241:6 felt 65:24; 66:6; 75:8; 89:1; 95:6, 15; 101:19;
112:12, 17; 184:18;
expectations 131:5 externai 161:8 129:14; 165:7; 206:24; 111:16; 12017; 122:22;
242:15; 261:4,6
expected22:16;26:5; extra 291:17 271:4 ;272:11 123:8; 125:15, 24; 126:10;
fairiy-at 112:1 141:10; 142:23; 145:22;
29:22;145:13;180:2; extraceiiuiar 82:5, 17 ft2W 5:2; 21:8, 13;34:13;
fairness 7:16; 291:14,20 151:21,22 ;160:17;
183:23; 186:20;
195:16; extraordinary 9:16 49:24;
50:4;
141:16;
239:16,25 faii 138:7; 290:12 172:10;
190:20;
195:2; 170:14; 171:12; 176:11;
extrapolating 29:20 177:9; 184: 18; 193:8;
ex ecting 238:1 faiiing 109:16 208:17;
210:8;
255:21
x extreme 105:25; 106:10; 203:22; 210:15, 18;
-P” enditure--you 132:9 faise 65:14 feWW 12:5,20;
35:14;
110:18; 113:12;120:13; 211:23,25; 212:1,2,6,7,
-pensive 49:20 173:15 ;240:17;241:25; famiiiar 5:9; 95:19 143:1
;202:16
18;213:17, 19,25; 215:18;
eXpt3rkfICe 5:8; 9:18; 242:6; 244:3,4 famiiies 11:7; 195:12; fibers 80:10 218: 19; 222: 13; 223:7, 20;
15:8; 19:25; 23:21; 26:15; extremeiy 31 :2; 67:17; 197:9; 202:16 fibrillation 47:25; 50:19; 226:2; 229: 19; 252:7;
30:19 ;44:21; 122:4; 68:18,19; 80:11 ;81:15; family 201:16 195:20 255: 16; 256:4; 260:7;
165:9, 9; 180:25; 191:25; 198:6 far 49:25; 90:1; 96:19; fibrin 47:19 266:2; 272:6; 277:8;

examination - firet (12) Min-u-seripm Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
Peripheral & Central Nervous System Vol. 1, April 28, 1998

282:22 10,25; 265:8 fundamental 105:1o gets 39:9; 149:10; 170:5; give-not 23:3
first-stroke 212:11 formal 105:14,15 funded 26:25; 39:21; 230:25; 232:10; 239:9; given 20:14; 22:19; 34:6;
196:17; 201:1 240:10; 242:6 93:23; 101:1O; 114:9;
Firstly 24:12 formation 79:19; 80:13;
--~, GI 35:1,9; 186:23 l~7:ll,12; 131:llj 187:3;
firstoff 128:13 81:10; 82:25; 84:21; 85:3; funding 6:21
GILMAN 4:3; 5:1; 6:10; 197:25; 202:ll; 2~:13;
fii 17:4,20 86:15; 87:15; 88:1; 200:21 funny 74:5; 236:16
7:19; 8:7, 22; 10:1,2,9; 234:20; 252:3; 280:24;
Ftigerald 27:5; 38:6 Former 195:19 Further 6:17; 8:19; 34:17;
17:23;18:5;19:2, 19;20:3, 284: 19; 289:6
Five 56:20; 60:13; 81:24; forms 164:18239:14 38:17; 41:6; 86:7,12, 13;
23;22:21;23:25; 25:6, 23; gives 42:22; 65:13;
115:7; 149:23; 173:2; formula 88:20 121:15 ;151:8,16; 177:16;
27:11,23;28:3; 30:20; 83:17; 143:10; 210:16;
175:5, 20; 176:22; 252:7 formulated 13:22 211:21; 221:13; 232:17;
32:20,21;35:20; 36:5,13, 215:24; 216:7, 25; 218:19;
235:22
fiXed 146:10, 20; 204:10; formulation 10:19; 23;38:24;41:16; 42:6, 24; 246:23; 249:25
253:3 12:18; 13:15, 18; 14:3, 12; furthering 201:2 45:4,13;46:22; 52:13; giving 10:1 1;26:25;
flash 279:24; 280:15 17:7; 19:12; 2013; 79:10; Furthermore 35:ll; 53:16;54:14;56:1,11, 24; 73:17; 119:19; 131:2;
83:9; 87:8; 88:16,19,22, 42:1; 45:17; 172:24 57:4,20;62:11, 17;63:22; 144:9;
flavor 19:14 164:10; 193:13;
24; 93:5; 120:9; 166:19; Fuster 37:20 64:4,16,19;65:12; 67:2; 276:23
flawed 261:14
204:22 future 45:8 69:7,8;70:20;71:22;
flew 94:16
formulations 14:4 72:12,21,23;74:7; 75:24; glad 262:2; 277:3
flexible 120:25 76:7,15;77:7;78:15,17, global 125:2
floating 232:13
forth 153:21; 155:20;
190:23; 204:5; 20616
G 25;79:3;83:4,7,9;84:4; glossed 67:4
floor 267:7 88:7;89:17;90:22; 91:22; glucose 183:8
fortunate 9:17; 125:25 94:14,17;97:15, 18;
Florence 18:1 gain 113:20;
146:16 GMP 90:3,5,7,9
Fortunately 50:9; 60:4 99:18,21,25;100:4,10,
Florida 200:25 Garrett 27:5 15;101:3,14,18, 24; goal 200:7
forward 37:16; 233:24
flow 47:6; 81:3;82:18; gastric 97:7 103:15;104:4,7, 21; goes 71:7; 230:3; 234:15;
193:24 found 26:18; 27:1; 59:17;
Gastrointestinal 4:21, 105:3,8;106:20; 108:13; 236:15
107:16; 108:17; 124:3;
flow-limiting 48:6 23; 8:8; 98:16; 181:3; 109:19;111:15; 112:6,22; GDod 4:3; 10:10; 47:3;
136:14, 24; 139:12;
flowing 80:7, 8;81:9 183:17 ;185:11,23; 114:2,11;115:4,14, 18; 6;!:~8; 75:17; lo9:24;
194:23; 218:4; 263:24
fluky 169:1 186:17 ;214:13
116:8,20;117:6, 24; 11.7:23;130:17; 140:15;
fOUr 9:8; 17:1; 51:3; 95:5, 119:9,25;121:9, 19;
fluorescein 81:12 24; %:8, 17; 115:6; 125:3; gather 76:12 163:22; 165:23; 170:8;
122:5,13,17,25;123:3, 171:24; 179:7; 199:5;
flyer 290:25 131:22,23, 24; 133:7; gave 25:9; 88:12; 114:22; 18;124:11;126:18;
141:6, 12; 145:7; 155:11; 203:9; 222:8; 228:15;
focal 48:12; 188:8,12 148:11; 224:6; 244:6 127:10,15,23;129:17, 24; 235:20;
170:6; 173:5; 176:22; 237:6; 241:6;
focality 247:13 GC 38:12 130:3;131:16,21; 132:15; 244:1; 249:14; 254:7;
190:9; 218:16, 18; 237:3; 135:25;136:18, 22;137:3, 255’3;
.#-k= focus 47:13; 51:1; 85:16; 251:16 gee 119:19; 238:17 258:3; 265:21, 22;
91:1; 153:12; 180:18;
6,11;139:1;140:1,6; 2+2;9; 285:22; 286:11, 16;
four-arm 109:4 Gehan-Wilcox 142:15
181:5; 184:6; 260:18; 141:3;143:15; 144:5, 16; 2$~:13,24
four-armed 14:17 Gehan-WiIcoxon 146:8;149:18; 154:22;
264:17; 267:1; 283:3; goofy75:16
215:19; 217:19 155:6;159:7,11, 19;
284:14 fourth 216:15; 252:17
gelatin 13:22 161:1o;162:8; 165:12, 20; Gordon 112:11; 113:8;
focused 90: 12;230:18; fragmentation 48:14 11.9:5
gender 96:8; 182:22; 166:21;167:3; 168:2,6,
287:14 frame 70:17,19 Gorelick 196:9,11,12,
207:4 11;169:22;170:1, 8;
focuses 184:4 frankly 40:9; 42:12; 126:8 171:22;173:18; 174:21; 13; 198:25
general 11:11 ;61:18;
focusing 40:22; 184:16; fraught 76:19 175:16;176:1, 5;177:5, government 7:5; 9:8
136:4; 142:5; 157:22;
185:22; 271:7; 287:19 free 215:25; 216:8; 19;179:3;181:9, 14; GPs 140:3
169:9; 174:16; 188:20;
folks 7:24; 155:1 ;231:2, 217:13,20 192:6; 194:16; 240:10; 187:10,15;193:17,20, 23; gradings 163:15
9; 266:22; 273:3; 282:15 Freedom 6:13 241:10; 247:9; 250:21 196:11;198:25; 199:4;
202:24;203:3; 209:17; gram 175:20
follow 17:10; 39:1; 40:14; frequencies 60:13 generalizable 160:14
214:25;220:4; 221:13; grams 26:20
69:8; 80:14; 95:16; 106:8;
frequency 35:8; 39:25; generalize 192:6 222:2;223:3,25;225:9, grandmother 115:21;
124:2; 138:10; 164:4
213:12; 255:20; 256:2 generalizing 275:18 14;226:6;227:11,15, 18; 1116:8
follow-up 24:3; 55:23;
frequent 12:20; 20:6; generally 20:1 1; 31:4; 228:6;229:1;233:17; granted 6:10; 11:23;
96:10; 111:14; 127:21; 64:8; 154:10
142:15; 151:15,16,17, 19; 141:9; 142:7; 147:18; 236:11;241:2;242:24; 2:!:11
153:23 ;213:1; 241:11 frequenter 125:21 164:5; 173:24 243:5,11,16;245:7,10, grants 199: 18; 201:2
frequently 73: 1;77:2; generated 90:5 23;249:1,7,9;250:7, 17;
followed 17:5; 96:1 1; granule 85:17
251:11,24;252:3; 254:3,
122:11,12 ;151:11,13; 248:25 generating 57:25;
frightening 49:13 226:22 7,11,14;255:3,8,14, 23; granules 13:25, 25;
190:3 256:16,23;257:1,7,12, 85:23
following 5:23; 6:7; 17:1; froiit 156:17 generation 84:25 graphically 151:22
15,21;258:16; 260:7;
39:2; 108:2; 134:14; fruitful 111:5 generically 43:22 261:1;262:7;263:2; grapple 168:17
191:20; 230:4; 264:12 frustration 45:9 genetic 28:20 264:5,15;265:25; 266:7, gratuitous 266:17
follows 11:18 full 9:15; 58:4; 73:18; gentlemen 16:20; 17:11; 13;267:5,15, 20;268:1,3,
great 61:16; 62:20;
Food 203:4 112:9; 129:7; 158:16; 79:13; 1%:12 10,15,19,22, 25;269:3,
108:23; 251:2; 258:15
footing 232:20 190:21 geographic 182:21; 5,8;270:1,11;271:9,20,
24;272:15;273:3; 274:6; greater 12:7; 40: 12;
forbearance 46:23 fullar74:14 207:16; 225:13
277:5,15,20;278:11; 50:13; 56:7; 72:18; 88:17;
Force 200:25; 238:22 fully 7:8; 155:22; 237:12 George 195:20
279:9;280:8,13;281:25; 136:15; 200:10; 213:1;
forced 75:8 function 36:16; 137:22; Georgia 199:24 282:21;283:11, 15; 2’14:22; 241:5; 279:17
forgot 264:23 183:8, 8; 198:21 Gerald 4:6; 9:5 286:24;287:10, 18;288:8; greatest 94:10; 152:25;
fOrm 98:15:135:21: functional 188:11 germane 46:2; 163:10; 289:10,22;291:1, 9; 202:2
163:19; 170:l;~176:2, 3, functions 133:4; 190:9 230:17 292:7,22 greatly 195:10
7,8, 21; 177:11, 15;247:9, fund 32:2 Germany 17:5; ginger 263:14; 264:7,8
—glreen
79:8 21:10

~er Reporting Company, Inc. Min-u-script@ (13) first-stroke - green


Advisory Committee Food and Drug Administration
VOL 1, April 28, 1998 Peripheral & Central Nervous System

Greg 17:2,14 175:1,


3;222:5,11,16,
24; hard 13:22; 31:22; hemorrhagic 255:4,7, Hospital 16:1 1; 24:3;
grips 252:6, 22; 257:22 223:5,7,11,
12;225:20, 116:11 ;131:15; 185:15; 22; 256:13,18,20, 24; 199:8
21;234:3,7,
18;239:19; 190:19; 244:19, 24; 257:2,14 hospitalization 234:1,2
#Q~TTA4:8,8;6:16; 9:l;
- 4; 88:8,9; 101:20; 240:21;
251:12;256:8,
8; 260:24; 261:24; 276:4; hemostatic 80:12 HOT 173,:6
1-J:15, 16; 104:5, 10; 261:17;
263:4,14,21,
22; 288:19 Hennekens 16:13; Houn 17:24; 18:1,1;
106:22, 23; 108:14; 267:24;
272:19;284:1,5, harder 175:12 21:22, 24; 26:14, 17; 282:25; 283:8
119:25; 120:1,7, 23; 16 hardly 44:21 32:20, 22; 34:23; 35:25; hour 48:16; 177:23
guidance 16:3; 45:11;
133:9, 11; 134:23; 135:2, hardships 202:17 36:4; 37:18; 38:25; 39:17;
hours 42:5; 136:17;
205:23; 207:9; 242:13;
20; 154:8, 14; 162:8, 9; 41:2,21 ;42:9;43:9; 44:15;
harmonized 15:17 140:20; 177:20; 188:10,
272:15,17
163:22; 173:18, 19; 177:6, 45:1, 9; 70:4,5, 21; 71:24;
hasn’t 31:9; 175:7 14
15;227:21; guidances 206:6
11,17;225:14, 72:15, 22; 93:9, 14; 94:6;
hate 258:1 113:7; 117:13; 119:10; Houston 4:9
229:2;
245:23,24;247:2, guidelines 37:20; 58:16;
have-you 220:22 130:10, 22; 148:19; 172:6, huge 60:24;68:2o;
8;258:20,
21;270:1,2; 59:4, 7; 61:17; 65:17, 19;
19; 23723; 23912; 240:9; 117:16;
251:3
284:24;
285:9,12,16; 121:24; 160:15 haven’t 26:1; 148:25;
241:9, 23; 245:12 Human 81:2, 9; 86:4
287:2
;289:11 guilty 287:13 149:21; 157:12; 225:23;
226: 1; 229:4; 275:5 here-but 288:3 hump 282:11
Grotta’s
90:24;109:19;
135:25;
164:13;289:19 here-in 224:7 hundreds 262:1
Haybittle 106:9
Grotto110:5
H head 61:23; 62:2, 3;
hesitate 19:11 Husen 194:5,8,9
ground 5:2; 224:7 272:13 heterogeneity 164:6 hypercholesterolemia
Haehl 10:5,9, 14; 17:23; high 11:4; 34:12, 15, 16; 182:19
group 11:3; 16:19; 21:25; head-to 61:22
18:5; 19:2, 23; 20:9,17, 35:6,6,8, 11;42:20; hypersensitivity 97:8
31:15; 32:25 ;35:2,2; 44:4; head-to-head 34:6;
20;21:21; 24:6,7; 25:23; 53:25;
55:13,14,18,20; hypertension 29:18;
46:6, 9; 51:14; 55:12; 40:13; 54:13,21, 25;
26:4; 27:13, 25; 28:18; 59:23;
60:8,12;63:24; 182:18; 197:21; 200:11;
57:23 ;58:11;59:2; 61:1; 61:23; 62:12; 63:14;
29:25; 32:10,15, 19; 92:23;
93:15;94:4,
5,5; 221:4
81:20 ;96:5,8; 99:18; 64:11 ;66:8,14
100:1,
18;102:2,14; 34:19; 37:4, 14; 41:17; 184:21;
198:6;214:3; hypertensive 45:16
headache 180:24; 233:3
103:23;104:5,10,11,19,45:22; 46:23; 47:1; 67:23; hypothesis 14:10, 17;
181:10; 182:4; 186:17;
25;105:3, 19; 68:9; 69:20; 70:3; 78:21,
23;106:3,3, highdose 55:4
93:4,7, 1’9;174:23;
22; 79:5, 6; 87:2; 88:24; 214:11 ;279:15,21; 280:3, high-grade 50:21; 65:22
107:3,4,8,11,19,
25; 175:11 ;206:15;220:21,
90:19; 93:4; 98:6; 100:17; B,12
110:6,7;114:5,6,8,9,11, higher 40:10; 42:15; 23
12,16;117:2,11;133:1, 101:7,16, 25; 102:8; headaches 98: 15; 56:9; 106:2; 151:6; 171:7; hypothesized 108:24
13;155:19;171:19,
19; 103:1; 104:1; 109:1; 183:17; 279: 16; 280:5 200:11,12, 14; 228:4;
172:14; 180:16,16,21, 23; 115:10,17;116:11;120:6, heading 116:4 234: 19; 2408
==S+.l, 2,4,6,7,8,8,11, 8;121:13,21; 122:7,18;
16; Health 4:9, 18; 16:13, 17; highest 94:ll; 180:21; I
82:1, 6;184:8,10,10,123:2,4, 14;127:7,12,
26:24; 39:20; 199:25; 186:7; 199:22
lz,14,20;185:1,5,6,12, 128:12,17,19,21,23;
13,14, 25;186:1,4,8,9; 129:3, 22;130:1; 131:22, 200:6; 240: 16; 241:24 highly 13:7; 14:23; 50:12; IC 38:12
24;133:17;140:14; healthy 38:7 57:16; 69:22; 71:8; 91:17; 1t25027:;20; 86:4,18
189:16; 190:25; 199:11;
144:13;149:17;162:2; hear 28:9; 101:24; 96:5; 153:4; 154:6; 158:7, idea 76:22; 121: 17;
207:12 ;210:9,11;211:13;
163:13;164:15;165:1,15, 106:23; 116:9; 162:4; 25; 159:21, 23; 206:3; 138:6; 238:11; 241:21;
213:3; 214:23; 217:3, 4;
22;166:9,25;169:24; 170:2; 194:3, 4; 203:4; 244:10 255:4; 290:24
218:9; 229:10; 246:19;
248:5; 253:12 174:10;176:1,3,7,24; 235:1; 239:1; 292:10,17 hint 171:1; 172:13; ideal 40:16; 133:17
177:8,
15;187:9,16, 17; heard 25:14; 46:7, 16; 234:15,17
grouped 115:2 identical 190:11; 220:17
191:6;
193:17, 22;247:7, 78:8; 110:21; 152:17; historically 22:24;
groups 28:21, 23; 29:5; 24;248:10;249:5,8,19; identification 104: 12;
168:11 ;225:20;226:1; 147:14
31 :9; 53:23; 58:25; 96:17, 250:6,
8;255:13; 256:15, 229:4; 249:9; 262:8; 195:23; 197:23; 198:2, 16;
23; 99:4,7, 23; 100:3; history 72:24; 97:7; 208:20
20;265:10 275: 12; 278:22; 279:4; 124:22; 146:19; 172:15;
103:21; 104:9,12, 13; identifications 104:11
Haehl’s 75:25 286:5; 292:8,9,19 198:5
107:24; 114:5,13,15, 25; identified 99:5; 140:23;
115:5, 12; 124:5; 125:3; half 33:25; 48:22; 82:10; hearing 56:22; 78:18; hit-and-run 14:7
143:8, 9; 177:20; 225:2; 193:25, 25; 194:7; 267:1 141:17; 148:8; 177:13;
147:17, 18; 151:4,6; HMO 143:21 185:7; 18,7:1;203:14, 21;
154:11; 169:12, 21; 170:6; 248:8 heart 20:7; 22:25; 23:14, hoc 93:16; 123:14 227:5, 6; 246:2,4; 247:13,
171:2; 174:11; 180:20; halfway 107:15; 233:8, 15,16, 17; 24:18; 25:2;
hold 135:24 22
181:24; 182:3; 183:11; 10; 290:23 37:25; 47:24, 25; 48:25;
59:6; 76:24; 182:16; holds 30:5, 6; 181:2; identify 22:24; 99:3, 24;
185:19; 186:19; 190:9,10, hand 5:5; 14:8; 16:7;
200:11, 24; 233:25 184:13 137:23
17; 200:2,3, 19; 210:4; 74:4, 18; 101:19; 248:3;
214:4,6, 23; 225:17, 19; 291:14 heartburn 245:6 home 24:2; 129:8; 174:17 ident”~ 107:23
237:3; 246:25; 247:6; handicap 182:24; 212:6, Hello 246:15 homogeneity 107:20; ignore 47:13; 167:25;
251:16,20; 275:15,21; 11,19 120:22; 125:2 271:14
help 25:6; 56:17; 66:4;
280:19 handle 262:23 103:12; 148:6; 165:24; homogeneous 26:14 ignOring 153:21
growing 85:4,22 166:1;
169:5;
245:1 homonornous 136:25 II-A 28:1
handling 291:25
growth 86:13 helpful 245:7; 277:16, 21; Honestly 185:14 [[[ 18:2
hands 30:17; 268:24;
guarantee 239:8 269:2; 292:3 278:10, 15; 292:24 honor 195:24 ill 9:2
guess 9:21; 25:15; 28:4; happen 24:2; 137:25; helping 164:11; 194:24 hope 9:3, 24; 66:24; Illinois 4:13,13
.--’-9; 69:10, 15; 92:3; 195:14 ;251:1;257:21 helps 280:15 155:16; 191:16; 196:24; illogical 260:13
, 102:22; 103:19; hematology 183:7 228:11 ;239:5
happened 46:17; 102:1 1; images 65:4
1u>:1O;
107:2;
108:20; 248:11 hopefully 180:9
110:6;
126:24;
137:22; hemianopia 137:1 imaginative 263:5;
happening 292:4 hemologic 60:9,22 hoping 146:16 292:20
144:23;
145:18;
146:2,
5;
147:11;
156:8;
169:9,
16; happens 231:8 hemorrhage 162: 16; Hopkins 10:3 iMSgine 130:8; 167:10;
170:20;
173:19;
174:23; happy 85:8; 193:15 189:3; 256:6; 257:16 horizon 67:1 290:7

Greg - imagine (14) Min-u-scripm Miller Reporting Company, Inc.


Food and Drug Administration Adlvisory Committee
peripheral & Central Nervous System VOL 1, April 28, 1998

imbalance 110:18 101:12,25;180:15; 259:14;


280:23;
291:18 103:23; 104:17; 109:2; hteraCtiOtIS
87:22;
imbalances 206:13; 181:10,21;184:3;
194:18; indicated 37:3; 128: 10; 120:16; 131:2; 133:13; 182:10,11,
14;183:3
225:13,16 1%:22;197:24;199:21; 154:19; 209:7; 235:5; 134:7; 140:13,15; 141:2; interactivity 237:4
214:4;230:23;
231:1; 253:22; 254:15, 18; 256:9, 154:19; 156:1; 179:1O, 17; interest 5:20,22, 24; 6:7;
immediate 67: 1; 204:23;
232:2;235:8;
239:10; 11; 263:23; 264:1, 20; 189:7, 19; 191:4, 10; 7:1,12, 16;23:10; 52:23;
208:12
245:25;248:2;
259:16,
23; 266: 19; 269:18, 18; 194:15 ;208:10;215:24; 140:9; 148:19; 152:25;
immediate-release
263:13;270:5;
284:5; 276:13 246:2; 248: 1; 250: 16; 169:9
12:11; 13:5,23; 14:4 272:12; 291:23
287:4,4 Indicates 37:22
immediately 19:4; 89:9 interested 52:1; 110:8;
incldences 200:11 informative 232:5; 139:17; 163:19; 164:17;
impact 11:6; 112:19; indication 11:18, 23;
inclination 73:2; 262:23 271:14; 277:18,24
116:12; 117:17; 122:20; 15:16, 17; 18:9, 25; 22:11; 200:3; 207:21; 236: 13;
inclined 262:13 39:7; 71:5; 75:10; 84:19; informed 104:19 238:6,7
123:6; 125:23; 145:19;
include 51:6; 75:12; 91:5; 154:20; 159:25; 193:6; Ingelheim 10:7,16, 18; interesting 9:4, 24;
165:5; 166:12; 174:8;
204:19, 22; 207:21; 12:8; 17:9; 98:1Q 179:10; 89:20; 93:11; 147:4, 13;
188:2; 189:10; 194:18; 97:2; 134:9; 155:23;
252:11,14,14,16,18,18, 199:16, 17; 246:16 161:13; 167:9; 212:5;
196:22; 198:1; 208:21; 166:5; 200:23; 201:4;
221:23; 230:20; 255:6; 19; 253:4, 20; 254:2, 4; ingredient 18:19 214:16; 258:2
225:25
259:21; 270:15; 283:7 255:20; 256:10; 257:5, 6; ingredients 144:3; interesting-and 232:24
impacted 175:8
included 28:24; 30:8; 259:19, 22; 260:6, 9; 215:12; 231:22; 237:2;
impacting 289:20 interests 6:3,4, 25; 7:4;
67:24; 91:13; 109:8; 266:10; 267:23; 268:5; 287:20
impairment 197:15 196:15
120:18; 122:16; 128:24; 270:15; 271:5, 6,7; inherits 160:3
impairments 195:9 272:22; 277:11; 278:13; interface 80:6
166:7; 256:21, 22; 259:14; inhibit 27:14; 35:15; 38:3;
imperative 38:22; 198:1, 279:11; 280:25; 281:11, interfere 90:8; 103:5
269:20; 272: 1; 278:13,20, 86:7,12
14; 201:20 22 17; 282:10; 283:5, 16; interim 97:14,18, 20;
inhibiting 27:9; 86:5
implement 198:2 285:3, 19; 286:22; 287:9; 98:1,2 ;99:7, 10; 101:9;
includes 33:4; 40:6; inhibition 12:19; 14:6;
288:21, 22; 289:3; 291:17, 102:1, 16; 105:15; 107:17;
implications 79:24; 199:25; 206:13 27:1,7,17,18, 19; 79:19;
24,24 108:2; 109:8,14, 23;
86:18; 203:24 including 49:19; 103:13; 85:9; 86:16, 21; 87:1, 12;
indications 22: 1; 209:10; 110:13, 17; 111:1,11, 18;
implies 227:1 139:10; 201:5; 202:2; 88:1; 89:11,25 ;92:18,18 113:19;118:2;120:2,4;
221:18; 267:13; 283:23 262:4; 264: 19; 269:20
imply 262:21; 267:3 inhibitor 86:3; 89:5 121:7,10,13,14;122:5,
indices 183:7
implying 238:12 inclusion 30:5; 33:8; inhibits 89:23 14,16;123:1,16,17,22,
43:5; 44:9, 22; 62:21; indirect 35:12; 49:18; 25;124:15,18,19;125:6,
importance 238:14 initial 66:2; 86: 14; 256:24
163:25; 176:21; 177:4; 65:3 13;126:20;127:17;128:1;
important 11:22; 14:13; initially 89:22; 108:23;
188:22; 193:4; 274:17 individual 31:8; 61:8, 11; 129:11,19,21;132:3;
15:7; 22: 19; 25:20; 26:9; 226:24; 246:22; 253:6,8
inconceivable 76:25 73:12;
81:11,23;87:16; 134:20;189:23;190:2;
27:19; 29:4; 32:23; 45:6, 8; initiated 30:5; 109:1;
inconclusive 270:17 142:25;145:7,
14;146:1; 220:10;223:16;226:14;
61:22; 64:18; 70:6,17, 19; 121:23
165:17;172:16;
204:14; 275:24
75:6; 81:16; 89:20; 99:13; inconsistency 219:9; initiation 226:21
205:12;236:4;
237:2; internal 85:19; 148:13;
103:23; 111:19; 113:25; 221:1
241:18;243:1;
260:18 injury 47:7; 80:5,7, 11; 161:7; 219:18; 220:13;
126:12; 133:11; 143:13; inconsistent 260:3;
individually 12:2; 103:4; 92:16 221:1
155:10; 156:9; 158:24; 262:16; 263:1; 270:18,19,
168:23; 169:2; 170:1; 166:17; 167:2; 208:25; input 282:10 internally 132:1; 156:10
21, 23; 271:19, 20; 272:7;
172:20; 191:14, 15; 242:19 insensitive 159:16
278:25; 279:3 interpret 222:5; 229:24
203:15, 22; 212:24; individuals 170:13, 15; insert 272:8
incorrect 33:11 interpretation 26:15;
213:25; 217:6; 227:23; 195:11; 197:19; 198:5
increase 87: 13; 90:7; insist 147:5 29:9; 52:24; 69:20;
230:8; 245:3, 21; 246:8, industry 200:2; 205:23 117:17; 143:23; 144:11;
108:11; 113:17; 116:6; insofar 84:12
10; 267: 17; 289:9 ineligible 248:13 230:19; 233:16
118:25; 120:2, 5; 121:7; inspirations 9:7
important-is 40:20 infarction 24:18; 25: 1,3; interpretations 208:22
122:20; 125:10, 16; 127:8; instance 140:16; 207:16;
impOSSd 197:12 131:7; 189:20; 201:19; 36:25; 37:2,5,9,12, 17; interpreted 61:15; 62:19;
208: 15; 209:8
impressed 249:15 216:8, 11,21; 217:4,5,17, 41:18, 20; 42:8; 48:1; 121:25; 276:14
49:24; 50:3, 5; 51:17; instantaneous 92:16
impression 65:14; 93:9; 22;220:12; 251:1 interrupt 5:13, 18; 97:16;
60:25; 76:18; 134:16,17, insteed 107:13; 144:9
110:15, 15;111:12; 112:3, increased 93:21, 25; 133:9; 143:15
11;119:19;
190:8 18; 170:16; 182:17; Institute 6:19
106:24; 126:20, 22; interrupted 282:1
195:10; 200:17 ;212:13; 250:12 instructions 251:4
impressive 158:14; interval 14:2; 52:13; 87:2,
249:16 216:7; 220:10; 226:15 infarctions 46:10 insufficient 22:17
20; 137:17
improve 200:19,22 increased-1 125:14 infection 24:23; 46:7; insure 14:1,6
134:21, 22; 170:17; intervals 52:15,16, 18;
improved 172:3 increased-that 125:14 integrity 7:6; 274:1 5; 53:23; 54:4, 7; 67:13;
250:11 290:16
improving 199:12 increasing 48:24; 110:3; 68:16,18, 20; 70:24; 71:2;
inflammation 36:18, 20; intelligent 65:2; 86:8
imputed 153:22 111:17; 121:2; 123:6; 91:5; 96:13; 98:8
124:4; 126:25; 223:13; 92:4,15
in-the 74:24 intended 43:7; 179:16; intervene 101:12,17
226:16; 238:11, 14; inflammatory 92:12 268:8
in-vitro 32:3 intervention 22:23;
275:25 inflates 105:17 intensiva 161:23
inability 70:15 198:10
indeed 8922; 90:9; 92:11 inflexible 258:8 intent-to-treat 142: 15;
inactivation 87:17 interventions 198:14,21
indefinitely 58:23 influence 9:18; 116: 17; 151:12
inadequate 43: 14; into 14:13 ;23:11; 27:19,
independent 15:12; 175:12, 13 intention 33:17
121:19 2!1;49:16; 53:23; 62:6;
16:18; 30:12; 87:14; %:5; influenced 107:3; interaction 14: 12; 79:21; 74:2, 25; 75:8; 77:16; 87:1;
inappropriately 292:5 113:4; 152:20; 205:20, 22; 120:11; 163:16; 289:18 80:25; 87:6,7; 143:12; 91:17; 92:19; 102:19;
inbred 250:19 207:20; 228:20; 271:8 inform 98:7; 103:2,9 145:5,13, 24; 152:18; 107:18; 112:20; 121:4;
Inc 10:7 independently 229:22; Information 6:13; 11:8; 156:23; 158:8; 160:22; 123:8, 9; 138:7; 139:9;
incidence 11:4; 33:2; 258:18 28:22; 32:10; 39:3; 58:14; 182:20; 220:23; 235: 17; 142:11; 152:3; 158:1;
48:24; 49:9; 60:3; 66:9; indicate 29:21; 244: 17; 70:14; 98:9; 101:9, 10; 236:16 161:25; 162:12, 21; 167:8;

Miller Reporting Company, Inc. Min-u-scriptm) (15) imbalance - into


Advisory Committee Food and Drug Administration
“VOL1, April 28, 1998 Peripheral & Central Nervous System

-170:3;
185:3;186:2; ISIS148:11 21;111:14,16;
123:12; law272:19
190:20;
193:25;203:4; Island 16:11 124:14,21;
137:12,13; L lay5:2
225:16;
229:15;231:24, isn’t-the 273:21 140:6,
7;164:4;
229:1,2; LDL 183:9
.--236:12;237:24; 230:3;
264:5,6,14;
isolated 76:19 lab 115:22,24 lead 17::16;48:1; 65:3;
:25;
246:17,21;247:1; 266:13,
14;272:16;273:1; label 15:21; 20:1; 24:23;
isolation 261:14 80: 17; 130:20; 180:9;
249:1;
256:13;257:16; 282:1
5;288:8,9;289:4,22 25:2, 2; 73:2; 74:2; 77:15;
issue5:24; 6:23;8:4; 214:7; 240:13
261:17;
266:21;277:7;
290:19 22:2; 25:12;30:16; 32:9; Kewas6:11; 10:3; 57:20, 140:18; 158:2; 166:11; leading 21:19; 48:19, 20;
34:24; 36:13,
23;38:5; 21; 58:10; 226:6,7,14,19, 193:3,6 195:21; 197:16,16
intracranial 47:17; 48:5,
43:3; 45:6;64:18,25;65:6; 21;227:1,9,14; 251:11, labeled 140:17; 164:12; leads 84:25
11;189:3
71:7; 75:8;82:16;8921; 12; 274:7; 283:18; 286:6 209: 10; 292:24 learn 91:25
intraplatelet
90:8 92:1Q93:13; 103:12; keep 28:5;
42:1685:13; labeling 11:15; 15:9; learned 45:17; 89:4;
intriguing 84:7 110:13,24,25 ;113:24;
90:11;99:2;
118:19; 22:11; 150:18, 19; 164:9; 271:16
introduce 4:4; 17:14, 25; 120:17; 131:8;143:24;
130:25;138:11;275:6; 165:25; 166:2; 167:5, 8; least 28:13; 38:11, 23;
88:4; 118:3; 203:14 144:23; 145:21;164:18;
281:9 193:9; 204:16; 205:9; 60:10; 71:12; 75:12;
171:4; 172:20;174:20;
Introduction 7:21; 10:8; 251:4; 257:6,8, 23; 88:11 ;112:1; 122:11,11;
229:4; 230:7,14;231:3,7, Ken 179:9
17:1,12 261:11; 262:24; 263:10; 135:7; 155:1; 167:5;
15;233:23; 234:2;235:3; kept 138:12
Introductions 4:2 273: 18; 278:20; 288:1,14, 172:12; 173:20, 22;
239:1,7,8,11 ;245:12; key 50:6; 79:22; 84:22;
if’ItUitiV(3~ 235:1 247:3; 251:23; 259:18; 25; 291:6,22 185:25; 188:2; 229:14, 14;
261:22; 262:14;263:7; 97:6; llo:14; 133:23; Laboratory 183:5,6 240:2; 243:8; 248:7, 17;
invariably 134:1o
264:10; 278:20;27%7,8; 143:10; 153:13 LACEY 4:12, 12; 9:2; 255:18; 262:5; 265:25;
investigate 37:8; 81:18; 267: 18; 272:3; 278:5;
286:3; 287:3;288:25; kick 39:22; 40:3 42:25; 43:1; 44:12,24;
165:7 284:2; 285:22; 286:11;
291:2,8,8,14,20 kill 132:5 270:23; 283:17
investigated 29:6; 30:25; 291:25
issues 5:15; 7:21; 8:9; killed 161:16 lack 91:ll, 19; 169:9
~~21f~81:25; 90:21; leave 17:23; 46:21; 73:5,
18:6; 29:15; 33:18; 46:7, Ladies 16:20; 17:1 1;
kind 36:11, 19; 54:4; 25; 187:11
20; 75:5; 78: 14; 106:5; 79:13; 1%:12
investigational 134:9 75:16; 110:17; 127:3; leaves 49:5
110:14; 162:3; 203:14, 21; laid 206:3
investigations 176: 17; 209:14, 21; 220:5; 234:8; 144:24; 145:1; 148:13; leaving 209:25
190:21 ;227:7; 251:2; Land 112:11; 113:8,24;
205:19,20 244: 16; 275: 18; 288:6 Leber 9:13,14
263:5; 287:23 119:5
investigator 137:24; it-why 169:4 led 68:24i; 197:5;
200:21
language 115:20; 263:6;
138:4,15, 17; 139:16; itself 33:2; 54:17; 70:11; kinds 244:17
267:8 left
4:5;
5:16;
77:22;
141:8; 177:12; 246:22; 198:5; 208:8; 262:20; kinetic 14:12 122:3;
176:12;
195:8;
large 28:20; 34:8; 44:25;
;~:9, 22; 248:2 280:1 Kinetically 32:13 222:25;
284:4;
291:5
46:19; 48:4; 49:5; 51:14;
“etigatordefinad ITT 210:1 Kingdom 218:17 54:20; 55:11; 56:16; Iegislatalrs 200:3
..~:ll,23 57:16; 59:14, 21; 67:20;
knew 84:9; 99:23; legitimate 224:23;
investigatordiagnosed
153:21 J 104:13,16, 22; 106:18;
114:4,13,15,16,16
69:3; 71:18; 76:25; 81:16,
18; 82:17,20, 25; 83:18,
260:21
lend 1%:24
investigators 16:22; 19,23, 25; 84:2; 86:16;
J 199:1 knock 26:7 Lenfant 39:21
30:15; 113:17; 126:21; 103:1; 109:10; 130:12;
James 4:8; 6:15; 88:4 knowing 5:17; 75:4; lesion 176:16; 236:19
127:3, 9; 130:25 153:2;
160:17;
167:17;
jargon 142:20; 143:2 102:14; 108:22 172:17;
206:18;
228:13; less 12:4;,20; 21:12; 28:7;
invite 24:9
252:25;
275:12;
292:6 52:5; 53:24; 119:13;
involve 7:10 Jim 163:3; 249:13 knowledge 30:19;
large-scale 12:9; 69:23 126:5; 147:24; 152:17;
involved 49:17; 104:24 job 85:9 106:17; 107:19; 127:4; 171:7; 173:9; 174:16;
John 16:16 149:4; 198: 19; 238:3; largely 288:10
involvement 7:13, 17 210:11; 217:14; 221:4;
Johns 10:3 262:5 larger 11:3; 35:23; 240:23; 241:3,6, 17;
involvements 7:4
known 20:1 5; 33:16; 108:25; 175:15; 228:9, 13; 242:1,6, 21,21; 245:6;
involves 109:9; 146:19 joined 10:2; 17:24; 58:25;
236:15; 241:7, 15; 265:1, 258:9; 275:22
involving 47:16; 199:15; 94:15 90:16; 95:8; 97:8; 103:24;
3; 279:5; 28621 lesser 157: 17; 159:15
209:23 judgment 22:17; 132:13; 107:8; 140:17
largest 46:6, 9; 110:7;
irrelevant 76:3; 236:22; 133:14; 244:10,25 knows 74:19; 172:18 level 86:25; 118:8;
160:18
244:13; 251:23 jump 93:7; 124:9 KONSTAM 4:1o, 10; 126:11; 127:18; 132:9;
last 8:22; 11:16; 25:8; 158:18; 190:7; 239:18, 22;
irreversible 87:17 June 249:25 6:1 1; 38:24, 25; 39:14; 26:8; 48:15, 16; 50:1 1; 243:9, 14; 261:6
is-and 105:11 40:14; 46:12, 14; 63:18;
junk 162:24, 24; 163:2,2 51:13; 68:12; 142:21;
64:2; 68:3; 69:7,8,9,19, levels 20:8; 87:13, 19;
is-but 251:5 justified 28:11 176:19; 215:7; 216:8, 14;
99:6,10, 25; 90:1; 93:15;
Iustify 255:19 24; 97:25; 98:20,23, 25; !64:16; 271:17; 290:15;
is-l 222:23 >4:11; 114:20; 115:3;
99:5; 127:23, 24; 128:4,9, !91:10
is-well 168:8 153:4; 197:15
15,18,20, 22; 129 1; asting 47:7; 136:16;
ischemia 10:21; ll:20; K 131:16,17, 25; 136:6; [88:14
Iti 27:2; 35:16;161:23;
18:11 ;254:16,20;257:10 137:21; 138:3,6,10,16, 162:6;
272:9
ate 84:16
ischemic 10:22; 11:2,3, 20; 139:14,19, 24; 144:20; life-threatening 97:9
Kaplan 215:24 ater 18:15; 19:7; 20:21,
11,20;14:19;18:12; 147:10; 167:4; 168:15; lifetime 14:8; 26:8
?4;45:7, 12;50:4; 52:23;
47:14,23,23;51:5;58:19, Kaplan-Meier 216:18, 169:20; 170:20, 24; 171:9, light 18::25;28:11; 257:23
~#95:4;97:3; 141:7, 18; 25; 217:12 ii:23;
67:7,9;72:13;
12, 17; 174:21, 22;219:5,
Kathy 4:20; 203:13 ~08:5;
120:17;
130:2; like-Dr 20:17
23;160:12;182:16 7,12, 15; 222:4, 22; 223:5;
. /:1;198:6;
204:18; ~R 4:24, 24; 7:20,
22; 233:18, 19; 235:15; 240:1; [51:9;
154:14;
173:3; like-it 274:13
212:24;213:17,19,25; 25:7, 8;30:21, 22;31:17; 255:15, 24; 256:7; 263:2, [74:12;
212:1,
2;238:3; likely 24:16, 18; 46: 16;
254:17,20;255:2,7; 32:3,13, 17;33:14; 46:17; 3; 264:11; 270:25; 272:10; ?53:7 50:3;57:16;167:19;
257:11,13,16,18;259:9, 56:11, 12;76:9, 10; 281:3,13, 21; 282:4, 19; .aughter 250:5 175:6;224:11
15 101:20; 105:8, 10;109:20, 283:19; 286: 16;287:1 aunch 195:18 Likewise 153:10;181:2,

intracranial - Likewise (16) Min-u-script@ Wer Reporting Cc~mpany, Inc.


Food and Drug Administration Advieory Committee
peripheral & Central Nervous System Vo]. 1, April 28, 1998

7;184:12 84:21; 90:24; 99:7; 7,10;39:18;41:4;42:22; manner 29:19 Mleede’s173:6


Lilia 4:22 102:24; 103:19; 106:8; 53:24;55:5,
17,20,21, 24; meny8:21;9:ll, 15,19, mean 25:17, 21;31:20,
110:4; 112:20; 113:13; 56:2,23;57:18,24,24; 19;46:%76:19,22,23; 23;34:2;36:16;39:7;
limb 288:3
117:2; 124:14; 128:1; 59:1;64:1;
68:19;81:21; B5:11;124:2;
126:15; 40:14;43:7;57:24;68:5;
limit 188:16 32:12;185:9,17;223:11,
130:9; 135:22; 138:22, 22; 131:18,19,22;152:8; 74:13;75:14;82:3,6,14;
limitations 31:13, 14; 139:4; 145:25; 152:11, 21; 18;244:5;245:3;274:25; 171:15;228:19;230:7,
9; $M5:21;
100:~103:16;
188:17 158:4, 10;168:6,23, 24; 284:13;287:16 236:19;242:8;
274:22; 104:19;105:4,5,19;
limited 31:22, 23; 32:1; 169:2; 170:9; 173:4; lowdose 30:11; 35:2; 276:4 109:21;110:19;111:23;
101:8; 291:12 180:24; 181:2, 21;182:7; 55:12; 57:23 ;79:15; 95:6; March 108:5 114:15;116:9;117:8,9;
limiting 286:13 183:13, 14;184:12; 185:2, 109:4; 154:3 118:22;120:3;121:1;
Mark 37:20; 199:1,
5;
limits 31:20; 113:6; 142:9 22;186:3, 4;206:10, 18; Iow-powared 156:6 134:24;144:25;145:4;
264:7
line 125:23; 157:24; 20715;211:3;215:18; lower35:13;
40:8,
17; 1!51:10;
165:24;168:2;
216:14,15,18,22, 24; marker 100:11;
286:25 171:13,17;172:12;
158:14; 193:8; 264:22 52:21;
57:6;
58:18,
18;
217:6,10,12, 20;218:21, ZJ:14;
151:4;
173:24 market 146:20; 263:14, 190:15;219:7,7,12,25;
lines 157:2; 230:4 24;219:2,4, 18;220:3, 22; 19;275:20;291:16
lowered93:24 2~20:15;
221:23;222:4,17,
lining 80:6 22919,22;230:8; 231:17, marketed 291:17 2(3;
223:3,3;224:18;
lowering 200:5
list 261:5; 274:8 18;232:21, 25;233:5, 9; marketing 146:17 2;25:3;
233:20,21;234:22;
234:14, 19;235:12, 22; lowest180:22; 184:25, 2.$0:2,
5;241:7;242:14;
listed 142:6; 221 :22; marketplace 290:13
237:9, 10;243:5; 255:9; 25; 186:8; 209:10; 213:2,
244:1 248:19;251:8,18;254:4,
12 Marv 72:25
listen 260:24 260:4; 261:20; 262:3; 5;,
255:15,17;256:1,12;
278:24; 284:19; 286:24; lunch 177:23,25 Marvin 4:10; 6:11; 2’57:15;
258:21;259:2;
listening 193:13 146:18; 167:4
290:11 ;292:15 263:22;265:4;266:15;
lists 170:6
literal 144:2
look-again 184:5 M matched 154:1o 267:3,
273:2;
11;271:12,
274:1,3,4,
13;
11;
looked32:6, 9;34:10, 14; material 5:9
literature 12:25; 13:1; 275:11;276:17;284:13;
51:14, 19;52:3, 9;53:24; M.D 199:1 mathematical 215:4;
69:14; 70:7, 13; 71:19; 286:5,18;288:12,17;
58:5,6 ;71:12; 100:19,23; 261:16
122:4; 223:24; 245:14,16 machines 162:7 289:12;290:10
102:17,21 ;112:12; metrix81:4,8,9, 11,14;
little 21:8; 28:6, 9; 35:21; 117:20; 129:18; 156:15; made-up 221:25 meaning 7:2; 20:6;
82:5,7,
17;84:3
43:2; 51:9; 52:5, 8; 58:6; 173:8; 174:18; 182:10, 10; magnitude 107:4; 117:15 ;232:16;279:19;
112:23; 157:17; 173:15; metter7:l;
73:21;74:l, 2:!30:6
60:5; 64:2o; 67:5; 72:24; 215:11 ;218:15; 222:1;
239: 15; 240:20; 241 :22; 13;78:11;
%:20;102:22; meaningful 154:21
77:18; 91:25; 96:24; 238:16;240:23; 261:14;
246:11 103:8;
117:18;
264:23;
103:22; 104:25; 105:3; 274:13 ;276:10 means 82:9, 23; 83:1 1;
273:5;
286:2;
291:6
107:7; 122:15; 143:19; kdhg 19:14; 25:21; mailing 201:6 84:1; 104:25; 120:10;
144:21; 146:19; 151:6; matters175:22,
23; 136:5; 143:4; 206:11;
31:1O; 32:2; 34:8; 41:7; main 23:21; 56:3, 5;
155:5; 157:25; 171:18, 19; 251:14 244:19; 256:18; 269:4
55:7; 59:15; 61:2; 62:5; 74:16; 98:14; 126:3;
174:19; 184:17; 190:18; 63:2; 66:7; 69:13, 15;72:3; 134:24; 143:2, 7; 145:24; maximal 12:18;
14:6; meant 89:10; 281:15
207:23; 225:12; 232:22; 76:18; 77:1; 98:2; 102:13; 146:1 ;168:13;231:21 42:21
meantime 163:21
233:20; 242: 13; 245:20; 103:12, 17;105:13; mSXimSlly35:15;38:3
mainly 98:15 measure 216:7, 12;
246: 13; 271 :9; 283:20; 110:16 ;115:8,9; 118:11; maximizing 41:14
290:21 maintain 86:24; 87: 19; 230:23; 261:13; 289:15
123:8; 128:6; 131:9; 233:11,12 IllSy 6:12; 7:7,8, 17;
liver 183:8 132:12; 138:24; 140:11; measured 81:4; 223:15
major 9:10; 19:15; 22:14; 21:21 ;24:22;30:1; 33:10;
lives 72:6 145:6, 15;153:6; 182:20; measurement 36:21
40 17; 58:6; 66: 16; 74:4;
207:11; 208:1; 210:21; 36:11, 17; 49:22, 25; measuras 116:16;
living 49:5, 7; 50:7 72:25; 99:5; 103:12; 75:6,19, 20; 76:4; 77:20;
211:8,11,17 ;212:6,11; 80:13; 92:12; 103:10; 206:12
local 6:16; 36:8; 80:11; 117:17; 171:20; 173:22;
213:10; 223:19, 22; 106:15; 109:23; 112:15, measuring 290:1
87:13; 133:14; 177:12, 13; 174:8, 12;212:8, 15,20
224:24, 25;229:15; 20; 113:7; 114:3; 118:7; mechanism 27:21; 41:8;
246:7 mejor-hy 38:18; 116:14;
232:19; 242:20; 243:15; 120:16; 121:9; 134:18,20; 79:22; 86:9,14, 21; 89:15;
location 176:15 253:10, 12;258:18; 261:8, 240:3; 267:18; 271:13
137:17; 140:25; 143:13, 90:10,13, 14;92:7,8, 21;
locked 112:19; 113:4; 23,24;289:16 makes 148:8; 152:20; 13; 148:6, 24; 161:23; 257:18
116:14 looks35:4; 69:16; 84:16; 172:11,11, 19;205:5; 168:4; 171:3; 174:19; mechanisms 14:11;
log 142:18; 153:19 98:1, 2;106:7, 13;113:19; 221:1,
20;222:13;224:5; 195: 17; 196:6; 202:9; 29:3; 79:25; 84:23; 87:14;
Iogran 142:17 118:2, 5;131:18,19, 19; 235:9;
276:4 205:23; 209:4; 221:5; 92:1; 94:1,2
logic 150:6; 263:21 132:3, 3;145:20; 261:7, meking31:12;72:14; 222:8; 225:12; 229:12, 21;
mechanistically 32:14
18;274:12 105:24;
125:22;131:10; 232:12; 235:22; 241:3, 8;
logical 183:25 mediate 174:19
loose48:2 145:12;
146:25;148:20; 249:19; 252:23; 257:14,
logically 264:12 166:22;
202:11;222:7; mediator 85:14
!OSi?279:14; 281:20 20; 266:20; 268:13;
long 12:20; 38:19; 42:10; 231:2;
235:16;
236:8; 271:25; 273:21, 23; 278:3, Medical 4:10; 6:19; 10:5,
92:22; 120:25; 251:9,15, lost49:19; 151:15, 17; 237:?0,
24;238:13; 14;27921,22;280:1; 15; 18:4; 194:17; 198:13,
22; 258:7; 263:18; 266:15; 153:23 245:21,
25;249:15,20; 289:7, 8; 292:16 2!0;199:6; 200:8; 202: 11;
278:8 lot23:8; 28:4; 40:16; 44:* 269:7;
276:5;
277:7,8 2!03:18; 230:20
maybe 20:21; 21:4; 29:8;
long-term 25:4; 42:16; 50:9, 11;74:19; 75:9; manageable 197:21 39:12; 69:10; 78:10; medication 19:20; 20:15;
48:19; 92:22 127:1; 167:3, 19;170:21,
managed 200:2 89:13; 91:25; 103:11, 22; 81:21; 100:21; 109:10;
longer 48:16; 85:11; 21;184:5; 187:3; 191:9;
management 11:5; 17:3, 105:10; 110:21; 114:4; 214:10, 19;253:2; 254:21;
137:17; 158:1; 161:4; 208:20; 217:8; 237:9;
18; 195:24; 197:23; 198:3 136:6; 138:16; 139:1; 268:5; 273:4
195:13 ;264:21 240:6; 243:20; 244:25;
157:12; 162:13; 165:25; medications 97:9; 195:2
248:19; 251:5; 272:25; maneuver 105:19;
look19:16; 21:15; 23:4; 274:7; 169:4; 172:14; 174:7;
275:11 110:10 medicine 209:6; 262:3
25:22; 32:4; 33:22; 34:2; 175:11; 224:17; 227:1;
lots 74:23; 228:16 Manfred 10:4,14 medium 34:ll; 53:24
46:21; 48:21; 51:9; 52:4, 8; 237:21; 247:2; 252:24;
53:2; 61:8, 11;62:8; 67:10; love260:24 manifestations 80:18 272: 10; 273:9; 286: 12; meet 162:21
69:9; 70:19; 73:1, 14; IOW 15:4; 34:15, 16;35:6, mankind 258:15 290:10; 291:22 meeting 5:25; 6:1, 2;

Miller Reporting Company, Inc. Min-u-scrip@ (17) Lilia - meeting


Advisory Committee Food and Drug Administration
‘VOL 1, April 28, 1998 Peripheral & Central Nemous System

8:22;
9:12;19:13;
57:15; 242:1, 5; 285:5 misinterpretation 34:13; 35:22; 38:25; motor 176:11,12
64:22;125:11;
129:7; Miami 16:14 273:13 40:11 ;43:5;48:7,21; 50:3; move 7:20;46:25;
94:18;
_~~:19;142:3;150:22; Michael 94:15 mislead 74:2 52:8, 11;53:11,25; 55:25; 149:20;153:15;
215:4
;2 59:17, 24;60:5; 61:3;
microemboli 48:14 misleading 7:23; 153:8; moves 91:8,
17
stings 5:3 288:14,18,25 66:16, 24;81:7; 84:12;
microgram 86:19 MOVhg 238:12,22
meets 15:23; 192:10; 86:9,10, 11;90:2; 91:25;
microgram/mL 86:4,20, misleading-1 288:12 MRI 134:6; 135:19
275:10 94:12; 105:1; 106:10, 25;
25 misleadingness 288:23 108:17; 11014;111:2, % much 9:21; 10:11; 23:4;
Meier 215:25
microphone 56:24; MkS 9:20,20 118:2; 121:8; 122:15; 33:16;3!2:2,
3;44:6; 47:1;
melena 185:10
169:22 missile 118:18 126:14; 136:14, 17;141:4; 60:20;70:14;72:18;
member 143:20 84:24;88:6;103:23;
microscopy 81:5,12 missing 79:3 142:19; 144:8; 148:9;
members 5:4; 8:24, 25; 112:19;121:2;133:14;
mid-trial 108:22 mission 194:18; 1%:21 152:17, 21;154:22;
9:1; 10:10;78:9; 94:21; 16(Y1Q164:1; 171:4, 13; 136:14;140:7;142:12;
105:7; 135:15; 178:3; middle 113:16 Mississippi 199:24 144:8;153:10;164:8;
172:13; 173:10; 175:6;
179:12; 191:9; 194:8; midst 59:6 mistake 165:25; 166:1 165:2;171:4,13;173:19,
180:17; 188:14; 195:16;
201:16; 292:23 might 17:20; 24:4; 25:2; 24;175:15;187:8;193:16;
mistaken 39:5 197:13; 201:12, 20;207:5,
membership 114:5 38:16; 40:10, 12; 44:7; 202:22;209:22;211:2;
misunderstood 177:3 B, 11,23;210:8;219:15;
Mernoria14:17 46:7; 56:17; 74:24; 81:16; 217:14;234:18;235:2;
mitigation 236:22 220:3; 224:10, 17;225:5; 238:18;243:22,24;
men 43:11, 16,18, 21; 88:16, 21; 89:10; 90:10; 228:8; 229:8; 230: 10;
99:7; 110:8,19, 19; mix 236:13 244:24;249:17,18;
97:2,3 231:13; 235:17; 238:13;
111:18)25; 119:6; 120:5; mixed 51:18,24, 25; 266:15;275:22;276:17;
mention 16:8;
125:13, 240:4,6,13,15, 18; 241:7, 279:5;289:18
15;272:7 125:6; 131:13, 14; 138:7; 277:20; 279: 16; 285:7
13, 17; 242:8, 9; 246: 13;
148:13; 156:4; 162:17; MMAG 24:13; 101:6; Muller 17:5; 27:15; 78:23;
mentioned 18:5;
29:23; 248:22; 249:14,14, 16;
204: 14; 220:3; 224:9,10, 133:1,2,13,18, 23; 134:5; 79:7,11, 13;83:4,6,8,11,
48:3;49:3;
54:12;
76:22; 253:16; 255:21; 258:9; 17;84:7;
89:20;
92:10
116:14;122:19;
127:17; 14, 21; 228:19; 229:3,14, 135:15, 16; 137:16; 139:7, 259:10, 17; 260:25;
16, 23; 230:23; 232:21; 11;140:10; 141:9, 10,11; mutticenlter 95:22;
128:19;134:14;
141:22; 264:22; 279:7; 280:5;
242:10; 243:18,21,23; 153:21;
162:7;
247:7; 160:17; 206:18
169:21;215:10;
221:10; 284:18; 285:18; 286:15;
245:13;250:8 244:1,6,10,11,12, 17; 248:3;
249:24;
250:13; 289:8 multidisciplinary
266:25; 277:6, 19; 287:24 251:6 199:10
mentioned-and 66:13 Moreover 160:13
migraines 163:4; MMAG-confirrned 139:5 multiple
103:12; 106:12;
merely 140:22;164:20, morning 4:3; 8:6; 10:10,
164:11,12 mode 203:4; 279:16 118:5,
5,5;145:2,20,20;
20 12;47:3; 92:11 ;94:16
Mike 9:5 147:7;
207:7,19;220:8;
message 267:17;282:9 model 79:20; 80:23; 184:21; 187:4, 18; 192:25; 234:8;
245:24;250:22;
~z*~ 137:16,
20;140:9 milligrams 26:2 81:17; 84:4,12,13 ;111:4 ?06:5; 225:20; 278:18,21 253:1;
261:7;
262:4;
million 49:7; 126:8; modeling 112:21 norning-thet 191:14 274:12;
275:16;292:10
a-analyses
108:8;
153:9; 195:7 moderate-sized 21:17
I>7:12;
159:17;
167:6 ~OrtShy 16:19; 19:9; multiplication
147:2
mimic 123:14; 162:17 modes 13:20 20:18; 21:1,6 ;22:4,6,18, MUltipliChy
Mets-analySiS
53:20; 118:4;218:6,
57:10 mind 40:9; 65:4; 85: 13; modest52:11;66:23; 25;23:4,9, 23; 24:7; 9,10
metaanalyses 12:3 139:21; 147:4; 242:23; 112:9,
17;157:20 ?5:11,21; 60:8; 112:2;
multiply
228:23
246:8; 254:21; 276:6,11 modifiable 197:20 [32:24; 133:1, 2,5; 157:4;
method 158:4;183:14 248:14
multitude
minimal12:19; 27:8; [66:12, 19; 170:13, 19;
methodologic 22:19; modification 94:9 mural 84:20
42:11,18,23;132:14 [73:25; 174:9; 193:2;
44:11;
172:20 modified 72:13; 210:1 [99:21 ;211:13; 221:12; must 16:4; 33:6; 93:25;
minimize 14:9; 26:12;
methodologically modify 257:4; 269:8 129:13, 15; 230:21, 25; 249: 18;263:5; 283:7;
38:4,16;41:8;206:12
106:11 molecuie85:17 !31:13, 17; 232:4,5,9, 10; 287:13; 288:2
minimizing 27:10; 41:15;
methodology 30:7; moment 16:8; 52:18; !34:5, 16, 18, 25; 235:17, MUtUdly 25:25; 228:20
206:13
117:9,23 91:1;106:21,24;112:7; [9; 237:11, 21; 240:5; MyOCEidkd 24:17; 25:1,
minimum 31:6 !46:18; 262:12, 17; 284:1,
methods 15:13; 200:19 116:20;127:25; 141:23; }; 36:25; 37:2,5,9,11, 17;
minor162:13;174:10, 162:4;248:3,4,6;266:6 };286:21; 290:3
mg 13:25; 14:5;26:5,6, il:18, 20; 42:8; 46:10;
11;212:8,
14,19 nest 9:14; 11:13, 14;
11,19,23,25;34:11, 11, morritor98:10 f8:l; 49:24; 50:3,5; 51:16;
22,22,25,25;35:3,15, minority
50:22;175:1; !0:6, 12; 21:11; 26:2o; 50:25; 76:18; 134:16, 18;
200:2;
261:10 monitoring 60:10, 22;
21;36:10;37:15, 23;38:2, 11:24;37:16; 44:4; 45:15, 170:16; 1!32:17;250:12
113:13,16;130:23;
15,19;39:6,16, 18;40:4; minus216:10;217:2,5 ,8; 47:9, 22; 48:2; 49:2;
274:14 myriad 197:18
41:12;42:4,7,15,18; minute5:15;
122:25,25; ;0:23; 73:11; 77:19; 78:4,
monitoring106:18 ;;81:13;93:1; %:20; myself 105:5; 114:25;
53:25;54:14,24;55:13, 142:20;
162:14
;234:13; 223:8; 23i: 18; 263:4;
Z76:
19;284:6;
286:6 monograph 39:8; 209:9 .12:18, 24; 113:25;
14;56:2,3,4,5,7, 20; 284:12
57:3,12;58:21;59:5, 8; minutes7:24;
34:13; monotherapies14:15; .26:12; 140:8; 142:9;
63:21;71:8,14;83:7, 9; i8:15;79:l;
125:10 160:21 .49:7, 15; 158:14; 167:15;
93:17;95:7;166:10; IIhOrS 155:24
month 96:22; 151:2; .72:5; 174:15; 18~:21;
.82:4; 195:19; 198:14;
N
204:11,11,12,13, 17; 177:9,9;195:17
MIS 23:1 1; 46:14; 77:20; !01:15; 241:12; 248:24;
208:12,12;209:9, 9; months 9:14; 55:16; ? 241:7
136:10; 172:2,9,9, 17; !60: 18; 262:3; 272:16;
259:20,22;265:1; 280:11 58:
15;60:11;96:13, 20;
?42:8;264:25 !75:4, 20; 277:21 mail 140:7
mglday 11:22; 53:24,25 )7:4;
116:24; 124:2;
nisdiagnoses 251:6 161:24;177:8, 10;190:3, nost~ 175:19; 251:13 name 10:14; 179:9;
~ 39:25;
__e 42:4; 45:16,18,
misdiagnosis 187:21; 16,16;197:4; 208:13 nother 16:23 194:9; 199:5
-?0;
51:11;55:7, 17;
e...2,
10;63:9; 73:13;
[88:1; 246:21, 24; 248:15; Morbidity 16:18; 24:7; notion 267:7,21, 23; lamed99:23
:49:21 lamely90:15;103:24;
77:17,19;93:20;94:5; 50:8;
133:1;211:12; !68:1, 2,3, 23; 269:5,6,
141:9,18;155:23; 156:2, nishrnash 251:2 246:18 .0;270:2, 11,12;271:1,4; 132:10; 149:11
12;173:1,9,13;175:5,9, nisinclusion 246:20 more 9:8;13:1; 15:7; !82:3 Iarrower 54:7
18.18;240:18:241:25: nisinclusions 246:24
. notions 277:8
19:7;
20:11; 29:16; 33:5; lation 195:21:197:17:
,.— .,
meetings - nation (18) Min-u-script@ ~er Reporting Company, Inc.
Food and Drug Administration Advisory Committee
Peripheral & Central Nervous System VOL,1, Aprfl 28, 1998

Neuropharm8:18 261:14,
21;265:20,22;
199:13
National 194:6,10, 13; Neuropharmacological
nor97:22;151:ll;
199:15
;211:14;
251:6 0 278:22;
291:11
195:1,17, 18; 196:9, 20; 4:25; 7:25 normal 137:7; 167:22; ol~d45:20; 250:22
197:1, 6; 199:22 Neurosurgery 4:16 247:12 O’Brian-Fleming 130:6 Dldenburg 17:5; 79:8
naturally 112:13; 155:24 neutral 74:25; 77:11,13 normally 83:20; 159: 16; o’clock 177:19,24 oitder 200:15, 16
nature 98:5; 106: 1; neutropenia 60:3,4,21 205:15 O’NeHl 229:10 230:1,1; omit 68:12
119:6; 191:4; 231:16; Nevertheless 15:5; North 199:3, 7; 200:24 235:1, 20; 236:23; 237: 19; m-treatment 180:1 5;
288:18 162:23; 164:2 239:1; 271:14 184:3; 185:22; 186:4
Northern 218:17
nausea 182:5; 183: 18; New 4:10; 8:24; 9:1; obesity 200:13 Dnce 36:10; 58:22; 98:13,
214:14 nose 272:6
45:2Q 55:3; 125:7; obey 19:3 18; 111:2; 115:20; 204:16;
NDA 8:7; 10:24; 191:14; not-because 231:2 246:3; 249:3; 270:12
176:10; 195:2,23, 25; objected 273:14
203:8 198:16; 201:12,20, 25; notably 15:7 me 9:10; 12:12; 16:22;
obscure 164:6
NDAs 160:16 202:13,19 224:7; 233:25; note 11:22; 12:23; 61:22; 18:8,14, 24; 20:5, 13;
observation 130:12;
near 137:18 266:2 73:18; 94:14 ;155:15; 148:7; 287:13 23:10; 28: 10; 29:7, 15;
nearly 173:14 next 16:7; 46:6, 9; 49:10; 184:19; 214:16 31:15, 20; 32:1; 33:5, 17,
observations 89:24
56:11 ;57:22; 78:23; noted 7:14; 31:14; 78:6 22; 35:4; 41:9; 44:19;
necessarily 25: 17; observe 236:6
105:8; 108:5, 13; 132:17; 45:16; 52:20; 53:14;
32:13; 75:13; 191:15; nothing 66: 14; 144:2; observed 13:9; 165:16;
133:25; 134:2; 152:22; 54:15, 16; 55:3; 56:15;
219:8; 222:1 1; 232:21; 149:5; 152:18; 156:21, 25; 186:13
189:9, 23; 215:24; 216:16; 57:5, 24; 58:8; 59:12;
240:1, 7; 264:9; 280:7; 170:25; 251:16 obstetrician 251:21
249:19; 277:13 61:24 ;62:1;65:8; 69:10;
288:4 notice 180:5; 184:7,9
next-door 178:2 obstetricians 249:15 70:16;71:18,21;73:2;
necessary 30: 10; 42:20; 74:5, 23; 75:12, 24; 89:3,
noticed 9:11; 222:19 obtain 27:16
129:23; 176:18 NHLBI 39:21 6; 90:23; 91:25; 93:8;
notified 104:7 obtained 6:12; 19:24
necessity 106:12 nice 75:15; 84:4; 147:19; 96:12, 22; 97:14, 23;
158:20; 175:24; 206:6; notion 121:1 obvious 31:14, 21;
need 7:12; 9:7; 27:22; 99:lo; 102:19; 105:15;
31:5; 38:11 ;85:11; 94:12;
259:2 November 108:2; 190:1 173:21 106:7; 110:12,13,14,24,
nicely 86:15; 172:2 obviously 54:6; 63:25; 25; 111:13 ;113:9, 13,25;
108:20; 112:20; 113:14; NSAIDS 36:8
111:23 ;112:18; 113:2; 115:19; 117:14 ;118:13,
120:24; 121:3; 131:1; NIH 26:25; 32:1; 33:12; nuances 272:25 136:12; 167:15; 183:20; 15;119:1,6; 121:10;
134:3; 145:1; 166:6; 196:17; 200:3
nuisance 60:12 185:16; 221:24 ;225:5; 123:3; 124:9,15, 25;
184:18; 200:4; 205:20; nine 26:9; 96:12 244:2; 245:24; 258:5;
null 220:21,23 125:16; 126:8,8, 24;
206:12; 208:20; 218:1,2, nitric 90:6 265: 15; 288:6; 292:19
number 5:10; 8:24, 25; 128:3; 131:18,21, 25;
14; 223:23; 225:24; 228:9; NMR 176:17 occasion 99:15 132:23; 133:3; 135:25;
235:22; 240:6; 243:13; 18:5; 33:7; 43:13; 46:24;
no-it 172:11 occlusion 47:18; 48:11; 136:23; 141:4; 143:1;
246:12; 248:23; 251:12; 49:5; 51: 15; 58:2; 69:3;
nobody 84:9; 106:18; 80:16; 168:13 144:9, 18; 145:9; 146:7,
256:24; 258:9; 265: 12; 72:6; 78: 13; 82:23; 83:2;
130:15; 258:9;287:2, 6; occlusions 47:9,14, 15; 18; 148:8, 13; 149:19;
273:11 ;288:6 85:15; 91:8, 17; 95:25;
290:14 141:15 155:16; 156:4; 159:16, 16;
needed 8:19; 31:3; 97:12; 101:18; 104:8,8, 160:2; 164:7; 166:19;
140:15; 173:2; 205:24; nodding 272:13 occlusive 12:2; 37:25;
19; 106:25; 109:10; 167:10; 168:12, 16; 171:4;
220:8, 11;230:13 noise 249:17 38:6,12,15, 20; 42:17
111:11 ;116:3; 117:15; 172:6; 177:9, 9; 179:12,
needs 8:5; 20:14 ;61:15; nominal 111:20; 113:1; 128:3; 130:23; 139:6; occur 38:9; 47:1 5,25; 22; 180:13; 183:6; 187:18,
62:19; 65:8; 103:19; 114:20; 115:2 60:12; 85:4; 89:25; 120:5; 24; 191:14; 195:5, 18;
150:25; 152:3; 167:18;
113:19; 114:17; 124:25; nominally 225:1 239:11 ;241:11 196:6; 206:7,19, 23;
169:7, 8;172:25; 173:2;
263:6; 276:19 non 43:25; 45:3; 65:20 occurred 24:24; 136:22; 207:7, 17; 209:24; 213:25;
174:5,8, 25;180:19,21,
negating 169:14 138:18; 175:4,9, 13; 216:16 ;220:25; 221:15;
non-established 109:11 22;184:19, 25;185:2;
negative 67:6; 91:11, 21; 180:21,22; 184:20; 185:1; 222:14; 223:5, 7; 224:5;
non-fatal 10:21; 11:19; 186:3, 7,8;188:17; 186:5, 7,8; 210:7; 247:5;
164:2; 237:5; 292:13 226:4; 228:1, 8,9; 230:10,
18:10; 19:22 202:10, 14;207:4, 22; 251:17
negatives 276:24 12,14, 15; 231:16, 24,25;
noncardiac-well 170:21 208:1; 210:10; 212:13, 25; occurred-as 96:20 23,2:14; 234:9; 236:2, 15;
neglected 287:15 noncardiovascular 220:15 ;223:5,16;241:3,occurrence 183: 15; 23,7:25; 238:3; 239:5,13,
neither 57:6; 100:21; 170:22; 285:15 4,4,5;248:1,6,8; 250:1; 184:7; 202:2; 231:6 15; 240:10,21,23, 24;
157:4; 251:6 none l18:12;132:ll; 253:14; 255:25; 275:13; 242:5, 6; 243:19; 244:2,
occurring 32:24; 49: 1;
net 40:8; 113:20 175:21; 191:1 279:16;287:25 17; 245:12; 247:12;
94:1; 140:19
Network 197:2 nonetheless 42:2; numbers 9:6; 22:16; 248:17 ;251:19;254:11;
occurs 44:21; 47:5; 258:4,14, 24; 259:4;
necrologic 47:7; 48: 12; 265:17 44:5, 6; 46:3; 56: 19; 63:9, 89:25
49:5; 197:11; 198:12,21 15; 67:24; 68:17; 72:8; 261:3; 262:13; 264:21;
nonfatal 66:2o; 76:1;
October 125:12 265:22; 266:24; 272:23;
neurological 8:9; 135:7, 77:1,17, 19; 78:5, 6; 91:12; 96:16; 116:6;
139:6; 151.17; 156:16; odd 77:22, 2 4;161:14 273: 10; 274:9; 275:8;
10, 14, 18; 136:16, 25; 134:25; 135:2,3,4, 11;
140:24; 176:16; 188:9,13, 150:14; 157:16; 158:23; 169:6, 21; 185:3, 4,9; odds 51:22; 52:6,12,14, 278:17; 279:22; 280:19;
21;7023;91:1; 155:12; 281:21, 25;282:5,7,8, 10,
17,19,22, 23; 247:12 159:12; 171:17; 172:9, 22; 189:17; 190:14; 210:22;
189:13 2:!; 284:19,21, 24; 287:3,
neurologist 133: 15; 173:12 ;204:18; 210:15; 211:8; 213:20; 216:14;
211:23; 212:1, 2; 238:2,4; 240:10; 242:3; 250:15; Off 9:7; 1 38:9;1 53:9; 21.,24; 288:3, 20; 289:6;
135:6; 136:1, 5; 161:18; 290:22,22, 24; 291:1,10
162:9; 163:1; 249:14; 239:6, 17;240:11, 15; 274:3 195:13 ;214:18
241:12,16, 19;242:5, 5,8; numbness 136:22 offer198:9,14,18,20 one-drug 224:3
251:21 ;274:22
244:20; 247:4; 254:15; numerical 56:14; 185:13, Office 6:13; 18:1; 230:2 one-liner 264:21
neurologists 64:9, 21;
133:12; 135:16; 136:9;
261:13, 21;283:6; 284:16 19,24 onaquartar %:23
often5:3; 23:3,6, 23;
139:12 ;161:21;250:19 non randomized 93:16 numerous 6:21; 43:19; One-third 195:8,14
50:4; 75:11; 135:18;
Neurology 16:10, 12; nOnSignifiCance 242:11 141:22; 142:5 136:4; 177:6; 231:8; ones 46:19; 85:15;
48:21; 199:2,6 nonsignificant 174:10 nursing 174:17 246:6; 247:15; 248: 11; 139:22; 152:24; 168:13;

Miller Reporting Company, Inc. Min-u-scripm (19) National - ones


Advisory Committee Food and Drug Administration
VOL 1, April 28, 1998 Peri~heral & Central Nerrous Svstem

236:7;
274:9;
275:21,
22; 13 overly 236:8 participated 37:18; 155:19;1!57:14;160:12,
290:11 ours 8:5 overpowered 228:14 199:14 19;161:2:2;
162:6,12,15,
~~~oing 31:10; 158:25 ourself 177:20 overview7:20, 23;17:3; participating 30: 15; 25;163:24;166:10;
‘11:6; 21:1;37:14; 47:2; 73:14; 94:22; 127:9 173:21,23;174:14; 177:6;
ourselves 260:17
‘;50:22;54:18; 61:24; 172: 15; 203:8; 246:16 participation 7:5 180:19;189:7,12;190:3,
out5:2; 8:7;20:22; 23:22; 20;192:19,20, 22;197:9;
64:13;67:12,20;72:4, 16; ~erviews 23:13 particular 7:1; 22:3; 75:7;
25:19;26:7; 33:15;39:22; 198:18;200:9,15;201:15;
76:11;78:10;82:10; 84:1; 117:18; 145:15; 179:14;
40:3; 46:5,18;55:3; 57:23; overwhelms 69:3 202:2,12,20;204:19;
85:5,14;86:4,14;87:4; 1%:18; 241:20; 245:13;
89:25;91:10;92:7; 97:23; 59:2; 66:3;73:5, 25;75:10, own 33:3; 70:12, 25; 206:22,25;209:23, 25;
24;77:ll,13; 80:13;91:~ 93:16; 106:1 1; 110:16; 252:20; 262:21; 263:11;
99:1O,15;102:23; 111:13; 210:8,23;211:1; 212:13,
92:20; 108:ld114:17; 132:5; 239:19; 252:23; 275:24; 279:16; 281:1
112:10;116:11;122:21; 14,25;213:2;214:1,17,
146:11;149:1,2; 154:12, 115:23, 24;117:1, 10; 253:2; 273:25 particularly 11:12; 19;221:4,4;234:6; 238:7,
18;159:4;160:21; 166:7; 118:24; 119:1 1;122:13; Oxford 16:14 24:16; 29:18; 49:23; 51:7; 9,10,23;:245:16;246:17,
172:6,9;174:24;204:24; 135:5,8, 22;152:5; 111:8; 121:6; 138:1; 20;247:1;254:16, 19;
oxide 90:6
211:22;216:20;218:20, 162:18, 24;163:2, 2,8; 194:1; 254:24; 271:24 256:8,20,22;258:25;
22;221:8;223:12, 15; 172:15;175:20; 176:8; parties 200:3 259:9,14;261:9, 10;
224:25;225:2,4;227:25; 177:11; 188:5; 206:3, 6; P partly 167:5 262:1;275:13;290:1
228:1,24;230:19; 232:7; 228:21,23 ;231:15,16; Patrono :27:6
Partnership 200:25
232:4; 234:7; 235:10, 25;
239:1;242:2;244:13;
247:12;250:21,25;265:7, 237:3; 241:24; 242:15, 19; p 99:14; 112:4; 153:16; parts 18:24; 243:19; pattern 157:22; 182:8
173:9; 215:21 ;223:11; 280:7 patterns 180:7
16;286:5 245:20; 246:9; 247:9, 10;
237:12, 13;242:1; 289:14 pass 262:13 Paul 9:13; 26:22
onset42:5; 176:11 258:18, 23;259:9, 23;
261:3; 264:3, 20;277:4; p-value 100:9; 106:9; past 40:22; 45:10; 75:4; pay 118:16; 153:10
open 78:18;193:25; 111:3,18,21,24 ;113:1, 197:4; 199:22; 263:22
194:7 281:8, 15;282:24; 283:1; PCNS 9:12
285:1,3,17, 18;288:3,13, 12,18;152:15 ;215:19,21;
paternalism 290:8 PDE 89:18
operations 7:7 216:17, 23;217:10, 18;
21 penalizes 292:1
opinion 193:2 219:16; 220:11 ;223:1; pathology 48:10
outcome 19:10;20:18; penalizing 291:15
opportunity 10:11; 234:15, 19;242:21; 244:3; pathophysiologic 77:2;
22:4,4; 27:25; 51:11, 21;
91:25;
168:3;
193:13; 245:4; 251:1; 254:24; 80:22 penalty 117:14, 16;
70:9; 74:16;76:13; 84:11;
194:2,
12;198:9,
20; 261:5,7; 284:14 ;287:l~ pathophysiology 93:1 126:25; 132:4
93:25; 106:17; 119:1;
202:23;
239:7 289:16 Pethy 16:16, 17; 24:8,9, Penix 9:1
120:15; 121:11, 14;
OppOSed 108:24;
138:23; 124:14; 165:3; 174:17; p-values 74:17; 97:22; 11;100:17, 19;101:5; PENN 4:15, 15; 6:10; 9:6;
165:16;
221:18
;267:1; 176:25; 189:10;249:6,7, 106:12; 119:12, 18; 133:18, 21;135:1, 13,24; 55:20; 36::23,24; 37:10;
~@l;271:13 3,21;254:8 120:21; 208:3; 219:8; 136:4,12,21, 25;137:5,9, 74:7,8, 21; 75:2; 165:23;
___ 220:8; 222: 18; 223:13, 18; 16;138:1,5,9, 14;140:14,
‘>site
113:11 outcomes 15:2 220:18, 25; 221 :22; 248:7,
229:3, 22; 240:8; 243:24; 15;162:4, 6;247:24; 18, 23; 253:25; 266:4, 8;
t+imal 27:8; 38:13; outlined 166:4 284:13 248:10,12,21, 24;250:9 267:3, 21; 268:8; 269:10,
42:18; 253:4 wtset 154:2 p.m 178:4,5; 179:2 petient 24:20,25; 38:22; 15, 17; 270:9,12, 19;
option 102:15; 120:13; Outside 69:25; 103:24; packet 252:4 42:2; 45:19; 46:17; 49:17, 271:19; 272:2, 14; 273:13;
202:13 245:1 280:21; 281:12, 22;282:1;
page 176:19 23;50:6; 55:5, 8;61:13;
optional 188:25 mtweighed 255:25 64:14; 65:20; 67:23; 291:9,10
options 66:2; 195:3; pairS 218:18
outweighs 7:5 100:20; 122:22; 127:1,18, mople 4:4; 5:3; 20:12;
196:25 pairwise 21:4; 147:17, 20;134:13, 22;136:1; ~2:24; 23: [4, 16; 33:7;
WE 161:6 23; 149:13, 22; 152:22;
oral 50:20 137:6; 140:9,11,12, 13; }8:18; 41:”19,22; 42:7;
3ver9:12; 14:2,4, 18,21, 156:25; 158:10; 159:3;
orange 157:25 156:14; 157:13; 162:20; 55:4;77:19,21, 23; 93:22;
24;16:7; 25:21; 28:19; 192:13 ;207:11;212:18;
Order 4:2; 68:2; 81:10; 166:18; 173:22; 177:1; )4:4,7, 11;112:15;
54:16; 42:21;49:14,23; 213:5, 23; 236:15; 237:15;
87:18; 101:7;109:8; 188:18; 202:9, 10;205:8; 118:23;127:2;144:9;
50:11; 51:15;55:8,20; 275:17; 276:5
112:23;
116:15;
122:20, 56:17 ;61:9,10,12;63:5, panel 75:5; 246:4; 247:11;249:3; 147:2;153:23;167:3,15,
167:15; 257:10; 259:5,11 18,19;168:1,9;169:16;
23;150:5;
162:21;
189:4; 5,7; 66:11;67:5, 15;69:2; 169:19; 193:12, 18;194:2; patients 10:21; 11:6,20; 175:2,
23;194:1; 195:6,
203:12;
205:3;
223:6; 31:3; 87:1,19;88:18; 91:3; 209:17; 221:14; 222:3 12:1; 1 4:18,20; 18:10; 15;199:11;200:10;
232:3;
233:14;
239:9; )6:24; 106:25; 108:24;
241:21;
256:23;
266:6 paneliStS 42:2 19:21 ;21:13;22:9; 28:12; i28:23;23,1
;4;236:19;
124:4; 125:24; 146:6, 10;
ordinary 130:6 151:23; 152:4; 171:18; panels 45:8 29:17; 31:5, 1 9; 34:14, 24; ?51:15;256:12;264:19,
paper 247:17 iO:22; 45:15;48:22; 49:2, 25;265:21;269:17,18;
ordinate 83:15, 17 174:11; 177:25; 187:8;
4,5;50:10,13,15, 18,24; ~70:8,
21;273:9, 14,23;
Organization 96:4;
195:4; 196:8;197:4; ~arallel 14:18; 95:24
199:22; 205:11; 206:22, 51:5,12, 15;52:2, 3,4,9; 274:22;278:9;281:3,8,
194:11 ~arenchyme 47:11 16,19;282:17,25;287:25;
24;210:17 ;211:7, 14; 53:2, 5;55:6, 12;56:17;
organizations 199:11; PARIS 68:5 57:19; 59:5,11, 15,21; 288:14,24;289:7
212:21; 213:7, 24;215:20;
200:22 216:14; 238:24; 241:11; parity 181:6 50:14, 25;61:2,7,9, 10, xsople-amd 266:2o
origin 32:16; 189:1 253:5; 259:1;280:22; Parklawn 6:14 11;62:2,5,7,8, 10;67:12; Zeptic 97:8
original 18:13; 106:25; 282: 11;287:8; 290:19 part 5:25; 12:14; 59:1; 58:2, 17;69:3; 70:22; Ser 11:4; ;21:13;49:16,
122:23; 123:13; 124:23; N/erall 21:5; 25:20; 44:1, 117:21; 149:10; 164:23; 71:20 ;76:1;80:2; 89:11; 19;55:12; 59:5; 83:11;
126:13 ;175:17;233:11 2,10,16;101:11; 107:20; 198:17 ;200:11;209:15; 91:13, 14;95:3, 25;%:2, >7:12; 107:25; 108:12;
originally 72:12; 107:12; 117:2; 145:23; 148:6; 242:3; 276:9; 289:1 2; 11,16;97:12; 107:1,24;
129:10; 152:4, 12; 156:16,
---
‘IO; 233:2, 13; 253:14 184:7, 11;185:17; 190:7; 291:25 108:9, 12;109:10; 114:7,
17; 171:1.!4;175:20; 190:7;
200:7; 220:1,2;232:12; Partial 236:22 9;117:1,2; 120:18,20; 192:19, 2C1,21; 201:14;
~rs 139:6; 144:21;
241:14; 244:20; 276:18 122:6,8,11,12,14,16,
150:21 ;176:18;291:24 participant 7:11 265:21; 28i7:7
19,23;123:9; 124:1;
otherwise 277:13 werconservative 113:3 Participants 6:3, 6; 7:12, >er-event 49:15
135:6, 14;143:1,5,6, 8;
ought 45:11; 105:19; nferhead 163:20; 170:9 15 148:22; 151:1,3,13,15, }er-treatment 248:5
109:20; 272:22; 278:5,6, ~ )verla~ 57:7 Participate 7:8 16,25;152:3; 154:23; 2erCeiVed 30:10;65:9,

ongoing - perceived (2o) Min-u-seriptal Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
peripheral & Central Nervous System VOL 1, April 28, 1998
10;130:19 281:25;
291:1 piiot 27:4; 201:1 piaying 148:20 49:8; 51:25, 25; 55:6; 61:6;
percent 11:25; 12:24; person-who 278:4 pity 258:17 pif?EISt35:14,17, 18; 112:14; 122:22; 127:1;
27:17, 18; 33:4,4,8, 8; personai 198:5 pivotai 12:23; 13:12; 10:24; 17:23; 20:23; 142:15; 145:8; 154:10, 16;
---
35:1,2,3,9,10, 10; 43:4;
personally 254:23; 14:16; 179:17; 195:24 32:21; 56:24; 69:8; 70:3, 171:5, 14; 174:9; 195:15;
44:2,9,13,17,22, 25; 20; 78: 18; 79:5, 11; 98:6; 198:8,11, 19;200:6, 15;
256:1; 261:12; 274:12 piace 17:20; 36:17, 22;
47:10,13, 23; 50:14, 15; 111:15; 124:9; 132:16; 204:8;205:8;
209:3,
6;
persons 105:2 38:5; 102:23; 117:4;
51:23,24; 52:6,6,11,12, 133:25; 139:4; 155:6; 210:1;225:17;
256:9,
11;
perspective 17:20; 125:11; 131:20; 178:2;
14,25,25;53:7,9,22; 169:22; 178: 1; 179:4; 259:5,11;261:11;
263:25;
21:22; 106:16; 180:14; 197: 18; 220:3; 275:3;
54:3,6,14;55:17,18; 248: 10; 250:7; 262:8, 10; 265:12;285:7
186:2; 191:19; 193:5 289:8
56:20,
22;57:2; 60:3,
13; 268:23 populations 23:12, 20;
63:4,6,8,8,11,11,12; persuasive 73:6; 84:16; placebo 12:12; 13:6;
please-l 162:4 29:15, 22; 51:18; 64:14;
70:24
;71:1;81:15;82:9, 148:9; 160:25; 207:25 21:12 ;27:1; 28:10,11;
120:22; 200: 16; 275:18
30:1,1,5,8,10, 13; 34:25; piS@SSd8:14; 270:9
18,23,24;83:20;84:1,1, pertinent 244:7 pOrtiOn 89:10; 179:16;
2;86:21;87:1;91:2,15; petitioned 21:25 35:2,6,7, 10; 40:4; 51:20; pienty 172:17
199:20
97:3;
107:13, 16;113:3; pSNitiOrrS37:21 52:10; 53:6; 54:18, 19; piugged iu7:18
56:4, 5,5; 57:12, 18; pose 174:22; 265:18
151:24;152:1,2,14,16; Peto 106:8; 113:24; piural 205:19
59:15,16, 18;60:21; pOSSd 154:2; 179:13;
153:3,
7;155:21,21, 22; 159:17 PIUS 13:5;
22:9;23:10;
67:20; 68:10; 70:23; 71:1; 243:7;
278:1
156:2,
3;157:2,4,9; Pete’s113:10 70:8;72:1;
73:8;84:20;
158:6,11,13,16;159:3; 82:5, 19;83:20; 88:13; Iposition 113:11; 252:24;
?1:2,14;143:21;144:10;
172:8,8,21,23;173:12, Phai 37:19 99:18,19;100:1,21;
146:7;149:9;
175:19;
258:16; 266:9
13;180:17;181:25;182:1; pharmaceutical 6:22; 106:3;
119:12, 23;126:7,
208:12;223:9;
228:12;
Ipositive 15:6; 58:17;
185:6;
189:7; 194:14; 198: 17; 200:2 9;131:4;148:12;149:9, B4:11; 95:14; 137:9;
234:1;238:8;
241:4;
201:14;210:11;214:1,11, Pharmeceuticais 10:7, 12,25;150:1;152:1,7; 147:6; 156:12; 161:14;
247:25;263:14 163:3; 164:22; 168:21, 25;
13;215:25;216:1,5,6,12, 16; 17:1o 153:6,11,12;157:12,24;
meumonia 24:16, 17 169:1,4, 14; 193:1;
13,14,20,20,20,22; pharmacists 200:1 158:15;159:4;180:16;
181:11,12,25;184:8,20; ~odium 17:24; 1%:8 219:16; 220:1, 2,2;
217:2,3,5,13,13,15,16, pharmecokinetic 17:6;
185:4;
186:8; 189:15; Ooint 18:7; 22:19; 24:1; 222: 14; 230: 12; 234:4;
17,21,22;233:13,14; 291; 79:9, 24; 87:5,6,21
207:12,14;208:13; }6:5; 30:4,4, 16; 31:12; 249:21; 258:25; 284:20;
238:1,2,19,19;241:13, pharmacokineticaiiy
213:13,15,21;214:12,
19; )2:23; 33:15; 39:20; ,291:21
14;242:1,2;245:14,15; 32:11
248:22;256:21,25;257:2 218:25;219:3;223:23; [1:22; 54:2; 62:19; 65:8; ~ositively 188:2
pharmacologic 11:5; r2:14;75:24;76:ll;
percentage 43:3; 138:7; 233:4;
249:3;251:20; ~ossibiiity 28:1; 118:25;
29:2;79:14 77:22;79:9; 84:8; 91: 10; 283:22
151:4; 154:25; 162:15; 276:7;
277:2;279:17;
pharmecoiogicai 17:6; 280:6 >2:14;97:24; 102:19, 20;
174:24; 185:1; 212:14; ~ossibie 76:5; 99:3;
.~. 79:9 [03:10; 106:20; 111:16,
213:2; 248:5 placebo-controlled [20:2; 129:25; 135:21;
~harrnacoiogy 89:22 !4; 113:25; 115:14; 140:8; 168:7; 189:2;
percentages 151:3 30:18; 54:1; 81:20; 95:23;
oharmogenic 80:8 [16:20; 117:6, 7,9; 119:9, 202:21 ; 208:22; 228:7;
percolating 230:5 187:22
Phase 28:1 [1, 16; 133:11; 134:23; 235:16
perfect 74:6; 96:22 pian 109:22, 23;121:10, !42:21; 144:5,8,9, 17;
~henomenaiiy 49:20 11;126:13, 14;128:14, 23; ,46:2, 3,4; 151:9; 164:13; :zossibly 5:19; 38:15;
perfectly 118:9; 228:7; ?2:11; 187:25; 229:16;
~henomenon 14:7; 77:2; 142:18; 265:9 .68:12, 22; 171:3, 20;
266:7
18&3; 290:2 pianned21:ll; 97:18; !32:20
perform 9:7; 69:23 .74:14; 181:23; 217:5;
Jhii 1%:9, 13 102:6; 109:8; 117:12; !20:14; 226:9; 227:16; aost 93:16; 123:14
perfOrmSd 28:19; 53:20; 121:13; 122:5;123:15; )ost-infarction 68:6
~hiiosophicai 113:23; !33:21 , 22; 236:8; 237:20;
57:11; 81:19; 84:8; 96:4; 126:1,4 ;129:1,5,9;
291:8 !40:5; 241:9; 243:9; )OStOperatiVI? 204:25
98:5; 122:21 ;123:11; 142:3; 150:9, 11;232:22
~hosphodiesterase !54:7; 261:20; 279:15; )otential 6:6; 10:25;
124:1 ;141:22; 151:16;
19:24;90:3,4 daIIS129:8; 142:2,4, 11 !80:13; 284:25; 286:16; 1.4:9;30:11; 76:14; 89:12;
176:16; 182:21; 183:3, 5;
Oiaque 79:20; 80:4,7,9; !91:11 1.39:20;182:10; 186:22;
189:4 ]hosphodiesterases
)0:20 >2:15 ~oint-then 146:5 ?88:17
performing 84:12; 109:9
photocopied 176:7 daqua-vessei 80:24 }Ointed 8:7; 25:19; potentially 33:5; 40: 10;
performs 159:17
Siaques 47:20; 48:8 i6:18; 66:3; 114:17; 1,09:16;197:20, 21; 222:7;
perhaps 18:6; 42:9; )hotocopy 188:5
109:19; 116:9; 242:13; ]hrase 266:22; 267:13 3iaSmS 27:22; 86:4,20, !28:23; 235:10; 241:24; ?88:6
25;87:19; 89:10,25 !46:9 JOwer 14:12; 22:5; 31:8;
264: 18; 283:23 phraseology 271:23
dated26:23 IOinter 191:21 14:1;67:16; 116:15;
period 5:16; 122:9; 152:5 ~hrasing 280:23
dateiet 26:7, 10;27:3,9, )OiIItifIg 235:25 121:19;122:1; 176:12;
periodically 105:13 >hysical 136:19; 137:1, ,85:14 ;233:3, 11,12;
19;35:15, 16;36:16; loints 40:15, 18; 153:13;
periods 162:18 [; 198:12 ?79:3
79:19; 83:2; 85:14, 14,18; !37:24; 243:1; 266:2
peripheral 51:17; 61:1; ~hysician 39:24; 94:8; 16:7,7, 12;87:15; 88:1; ‘OiiCy 18:4; 74:8; 78:9, tower-weii 176:11
141:14; 182:16 [36:2, 5; 16618; 2652 ~:5 7;93:21; 94:1 4; 102:22; 117:18, 20; }owered13:13; 44:16;
periphery 177:2; 250:24 >hys]cians 17:17; 37:19; 46:19; 148:4; 149:15; ;1:8;
72:9; 260:4
~ieteiet-and 14:8
permit 21:23 i9:2; 105:6; 173:8; !62:14; 264:9; 279:7; mwerfui 15:3, 13;44:4;
]iateiet--you 14:7
permits 281:5 99:25; 202:20; 240:16; !87:14 !25:6; 241:8
!41:24; 269:21; 273:20 )iateietdependent 27:2
permitted 256:13 IOiio 250:22 tractical 65:6; 291:8
physiologic 39:3 }Iatelets 12:19; 26:9;
permutation 115:1 ~7:7; 32:5, 16;38:3; 47:19; loliticaiiy 33:10 WaCtiCe 192:7; 209:5
.- >]f5:q6
*. permuted 114:19; 10:9; 81:13; 84:25; 85:2,5, )001 28:20,21 WaCtitiOner 247:10;
190:24 ~ick 251:7 [8,
24,25;86:9;
89:5,5, 100ied58:11 ?50:10;251:6
person 22:25; 23:1, 1; ~icture 21:5; 116:13; [2;92:17 IOor201:18 wactitioners 250:21;
42:4,16, 19; 104:20, 24; !06:5; 231 :20; 272:22 dausibie238:1,13; ?91:7
10pUiatiOn28:13,
15;
130:1 1; 134:20; 136:25; tiece 141:2 !41:12 wagmetic 126:16
3:12,16;37:7,
8;40:21;
146:14; 254:11; 272:8; ~ills 12:20; 202:10 day 92:19 1:17; 43:7; 44:3,9, 20; magmetist 120:24

Miller Reporting Company, Inc. Min-U-Script@ (21) percent - pragmatist


Advisory Committee Food and Drug Administration
‘VOL 1, April 28, 1998 Peripheral & Central Nervous System

pre-NDA 19:13; 129:7; 155:11;


242:4;
275:25 principal 94:22; 142:24 6:22;
7:17;
8:1,
8;16:3; proves 144:1
142:2; 150:22 prassing 46:24 principally 137:21 206:1;
263:6 provide 16:4; 66:23;
~cedent 108:20; 121:5 pressure 182:18 princ[pial 291:4 professional 11:15; 74:14; 125:19; 179:17;
_-
‘;eding 14:18 prestated 128:1 principie 16:22; 107:21 58:25; 150:18; 1%:15; 191:10; 258:25; 279:22
p, ecisely 20:9; 136:14; 197:3, 11;199:12; 200:23;
presumably 31:19,22 principles 121:1 provided 169:24; 188:19;
163:9 201:3
;204:15 199:17; 246:1; 252:10, 12;
presumptions 166:22 priOr 11:8;12:1;15:8;
preclinical 29:1; 88:2 professionals 194:17 279: 10; 280:16
presupposes 206:8 19:25;
27:5;37:7,24,25,
preclude 5:25 25;67:10;
88:10;
91:11; Professor 4:15; 16:10, provided-but 184:6
prettier 206:5 12,14, 16;24:8,9; 199:1,
predefine 102:1; 95:3;
97:5;122:4;
125:16; providors 200:1
pretty 23:20; 117:10; 6
206:15 ;234:21,24 165:8,
9;182:15;
188:22; providos 95:14; 192:5;
181:14; 237:5, 18; 244:5, 210:7 profiie 26:21; 34:18;
predicament 251:10 22;26&15;291:19 42:14 ;60:2Q 66:7,8,12, 245:17; 246:19; 265:4;
priori 32:25; 232: 15; 284:7
predictable 60:6 prevalent 195:16 17
238:1; 239:25; 247:16
prediction 49:9 prevent 20:13; 42:3; profiies 180:1 providing 194:14;
probability 171:7; 204:12
predictors 153:18 66:25; 77:17, 18; 95:3,7, 184:22 profit 1%:21
prefer 18:7 9; 198:23; 204:25; 245:16; prOVk$itMI 125:5
probably 9:1 1; 25:22; profiiabie 220:3
273:5; 276:7; 279:21 proximity 85:4, 22; 86:6
preference 142:17 39:11 ;74:13; 112:21; program 107:12, 18;
preferential 86:16 prevent-that 109:9 pubiic 178:1; 193:25, 25;
117:17; 119:3; 128:25; 191:3
prevented 42:17; 130:7; 135:6; 175:i8; programs 7:6; 200:22; 194:4,7, 16; 195:19, 22;
preferentially 89:23
192:20,21 206:4;
22%7,8;230:18; 201:5 199:12; 200:8, 22; 201:2;
prejudice 271:3
preventing 37:9; 51:4, 235:22;
243:25;
260:21; 202:25
preparation 41:7; 72:1, progress 50:9,11
10,20, 24; 54: 10; 55:7, 25; 276:19;
277:6;
290:9 pubiish 84:10
7; 79:16; 81:22; 86:24; prOgK!SSiOtI 232:9
59:12,18, 25; 66:1; 78:4; probing 231:12 pubiished 11:15; 15:8;
87:3,18 progressive 198:11,12
92:9; 164:12; 194:24; probiem 18:21; 34:4; 17:16; 51:13; 58:4; 59:3;
prepare 98:13 200:19; 234:6; 286:11, 21; projects 1%:17; 201:2,4
50:6; 73:11; 76:14; 84:16; 64:14; 1 12:12; 174:3;
prepared 19:5; 20:25; 292:25 WOiOnging 272:8
102:11 ;115:19; 116:7; 205:24
123:25; 265:13 prevention 11:11, 14; woiongs 272:9
118:6; 145:12; 161:17; publishing 113:8
prescribe 143:22 12:10, 13; 13:6; 14:25; 164:10;
173:4;226:4; wominent 289:8
prescribed 253:14 15:2, 14; 29:13; 31:4, 24; puimonary 141:14
227:8,
21;228:4;234:13; Wornising 198:16
prescribing 146:6 37:15, 17; 38:15; 40:5; 236:5;
251:7,
8;254:25; punctate 36:8
42:19; 45:25; 50:10; xomptiy 79:1
prescription 74:14 260:5;
261:9,
23;263:4; Pure 92:25
61:17; 64:8; 66:20; 79:17; 265:1,15,
18;272:2; 3r00f 279:1
pUK3iy 4E1:1O;
176:23;
~+fi~ription-labeled 91:16; 94:23 ;160:18; 275:16;
276:12;290:5; xoperiy 50:16 177:5
173:6,7,11, 12;191:24; 292:3 ]rophyiactic 42:3
~. =sence 86:1 1;93:15; purpose 98:2; 147:10;
192:14;193:9;194:20; probiem-i 260:5 wophyiex 75:18
183:19,21 204:17; 205:14; 206:4, 20;
196:10,16,17,19;197:4,
problematic 229:13 wophyiexis 42:11,16, 242:25; 254:22
present 6:6; 10:11;17:2, 5,7,10;198:10;200:24;
probiems 72:25; 84:13; !2 purposes 249:4; 264:17
3;26:19;79:8;
94:22; 201:3,11,21;202:7,
13;
97:13;150:1,4;
188:1; 246:11;254:12;271:1; 208:14 xoportion 58:10; 82:20, Ourpural 60:8
189:24;193:13,21; 277:2;
282:16;284:15; procedurally 266:5,11, !2; 83:18, 19,22,25 aut 34:19; 45:20; 59:2;
203:17,18;207:23; 285:21;286:10 14 XOpOSai 78:22; 129:6 51:16; 65:3; 69:19, 24;
209:19;255:10 prevents 154:3, 4; 287:7 procedure 103:7; 247:25 wopose 19:12; 28:15; 70:3, 10;74:23; 75:18;
presentation10:23; PR?ViOUS5:8; 7:17; 30:9; procedures 98:7; 232:3 .01:16; 191:19,20; 193:1; 77:15;11.5:20; 116:1,13;
11:1;
19:5;20:21,22;21:2; 55:21; 67:5; 68:3; 77:4; proceed 79:5; 179:3 !66:5 139:9; 150:10; 155:12;
78:24
;90:12;155:13; 38:10; 90:25; 127:13; woposed 18:9; 59:7; 161:22;
162:12;
164:3;
PROCEEDINGS 4:1;
161:3,
11;174:2; 179:16; 162:22; 182:17; 188:17; 29:8; 150:19 RO:14;1.85:15;
186:2;
178:4; 179:1
190:22;194:3;
203:1,12; 246:3; 247:4; 275:5,7 mospactive 25:15;
Z44:19;
246:21;
257:5;
209:15;291:12 Process 80: 12; 92: 12; ~90:25
meviously 46:16; 68:23 205:15 ;274:18 10:1
Presentations 10:7; wospectiveiy 76:21; Suts75:3;
282:2
wice 118:16,17 woduce 135:21
67:9;
203:7 09:22; 117:12; 121:10; rotting 163:4,5
Wimerily 75:21; 186:17, woduced 163:21;
presented 17:8; 43:2; 19 24:21; 167:23 JUZZiSd 35:21
170:12; 213:6
55:10; 98:17; 108:6; wotect 206:14
]rimery 19:7; 21:3; xoduces 212:21
160:6; 166: 15; 190:6, 12;
191:16,20; 193:21; 204:1;
72:12; 73:7; 76: 13; 77:3;
[02:13; 103:13; 120:12;
woduct 6:17,23, 24;
7:10; 10:19; 13:14, 22;
wotection 42:21
wotocoi 18:13; 97:14;
Q
206:4; 237:13; 260:10;
[21:17; 124:15, 16; 126:1, 9:9; 102:19; 109:8;
272:4; 273: 16; 275:9; 15:25; 167:10; 179:24; 2iD 14:5,
}; 128:2,13,14,15,17, 20:10; 121:14,23;
290:17; 291:13 183:19, 21; 186:18; ~uaiified 170:13
[8; 129:2, 9; 132:19, 23; 23:13; 124:24; 126:4;
presenters 78:17 192:11; 203:22, 23;
[33:15; 142:8, 13; 150:9, 28:9, 12; 129:6, 13; ~uaiify 136:24; 137:2
presenting 8:16; 147:25 104:15,20, 23; 205:4,5,
[2, 16;151:22; 152:11, 12; 32:8, 22; 141:13, 17; Iuaiifying 96:8,19,21,
11;207: 10; 208:10;
presents 184:3 [53:16; 156:14; 158:3,3, ~lo:14, 16,25; 211:14, 18; 42:13,14, 16; 150:2, 17; !4; 163:1~ 182:15,23;
preserve 198:21 i; 159:24; 167:24; 173:5, 52:13; 190:6; 204:4; ~87:19, 20; 188:6,19, 21;
?12:12,21; 213:6,11,15,
[1; 196:16; 197:7; 204:4; !4; 214:17; 221:8; 223:6; !08:14, 23; 217:24; [89:5, 9,12, 16; 210:3,22,
~$eserved 115:1
?08:19, 20;211:7; 218:2; !25:21;
226:10;
248:14 !3;211:1; 213:10,13,14
‘;erving147:8 ?63:8, 12; 264: 13; 265:6,
?20:5;226:11; 227:6,7, lrotocoi.-iet’s 124:23 ~uaiitative!y 119:21
~sident 10:5, 15; [1; 269:12; 270:14;
[2, 19; 228:8, 18; 230:7; 287:19
194:5, 10; 195:20 wotocoi-pianned 97:11 ~uai”~ 221:2
!31:18, 19; 232:15;
prespecified 111:10; !34:21; 238:22; 247:21, woduct-and 263:11 lrove 168: 17; 228:17 ~UantitWe 111:25
120:3; 121:6; 126:4; !2; 250:11, 14; 253:5,6; productivity 49:19 lrOVSd 127:15,16 ~uantitative 81:4
136:9 ;141:13; 143:11; !75:24 %oducts 4:21, 23,25; woven 60:23; 108:9 ~uarter 225:4; 248:8
——
pre-NDA - quarter (22) Min-u-scripti ~er Reporting Company, Inc.
Food and Drug Administration Advisory Committee
peripheral & Central Nervous System VOL 1, April 28, 1998

question-does 105:12 151:19;173:25;182:1; 17;289:12, 20;292:14 redesigning 118:19,19 reginwn 165:6


questionable 223:16 185:7,
17;214:12;215:25; realm 291:13; 292:4 reduce 11:19; 18:9; regimens 66:22
questioned 7:7 216:8,9,10,25;217:4,13, reason 20:11; 32:25; 75:25; 151:17; 166:19; region 182:22; 199:19,
16,20,22;218:3;242:2 40:16; 53:10; 58:18; 174:8, 9; 194:18; 196:22; 23; 200:9; 201 :8; 218:15;
quick 56:12; 150:15
t’ateS
32:24;35:1;104:14; 64:22; 75:13 ;99:11; 254:15, 18; 256:10; 260:1; 220:2; 224:25; 225:11
quickly 182:7
107:11,18;117:11,11; 127:11, 12; 139:19; 280:1; 284:4
quite 8:23; 31:19; 52:17, regional 220:19; 244:18
131:3;
184:9, 11;199:23; 161:21; 166:5, 6; 167:16; rSdUCSd 73:9; 82:22;
24; 57:6; 72:8; 82:11, 24; Iregions 201:22; 218:16;
200:12 169:1; 205:19; 221:5; 83:24; 233:12; 242:10;
84:23 ;85:15; 107:10; :219:10;220:17; 225:2,3,7
rether 91 :2o; 248:25; 230:21; 231:24; 235:4, 25; 255:19, 20; 279:2
113:11 ;114:1; 116:5; Register 58:17
250:14; 260: 12; 277:? 243:12; 251:18; 278:14; reduces 10:20; 148:21;
119:22; 131:6; 134:24;
279:8; 283:11; 291:8 289:19 259:16, 23;263:12; 270:5 registered 98:14
153:8; 163:14; 167:14;
172:4; 229:23; 240:25; retio 192:16; 258:8 reasonable 18:24, 24; reducing 160:1 1;174:5; registration 19:12
rational 14:11; 92:21 25:22 ;101:11,15; 111:8; 202:1, 10;204:17 Iregrettably 265:20
242:17; 245:5; 251:13;
271:11 ;276:22;289:13 rationale 10:25; 17:7; 112:4; 125:22; 161:1; reduction 11:24; 15:5; regular 24:3; 38:13, 22;
26:1; 27:15; 32:1; 79:8, 12; 187:5; 210:2 22:8, 16;37:5; 51:22,23; “102:13;2O3:4
quote 132:21
9212i:09:13; 125:7; reasonably 112:5; 52:6,7,12,12,14, 25; regularly 117:5; 137:20;
quoted 153:7 53:1, 8,9;56:6; 573;63:5; ;289:4
254:24
quoting 58:16 66:23; 70:23; 71:2;82:4,9,
rationalize 222:12 reasoning 167:14 regulated 6:4
14;83:18, 20;91:1, 15;
raw 184:25 reasons 12:8; 35:17; regulations 205:4
R re 107:10 172:3; 221:22; 231:25;
107:13;
155:21;
152:14;
156:3,4;
153:7;
157:3,4, Regulatory 10:5, 15;
248:14 :193:5
m-evaluated 130:17 9,20;158:6, 11;159:4;
races 28:16 reassessed 120:9 166:11 ;172:2,8,9; rehabilitation 194:21
re-ran 191:3
racial 30:23; 31:8, 15; reassured 162:10, 11 175:15,18, 18;189:13; reiterate 25:9; 278:11
re-review 150:10
275:21 reassuring 240:18 208:4; 216:4,5,15, 22;
reach 76:4, 6; 99:14; 217:2, 15,21; 241:15; reiterates 284:25
raise 5:5; 102:22; 191:15; rSCail 237:8;280:4
141:2 ;187:5; 211:2; 242:2; 254:12;256:2; reject 220:21
261:6 receive143:6
219:8; 220:19, 20; 229:19 257:9; 262:17; 263:15,24; rejected 139:7
raised 110:25 received 6:21; 143:5;
reached 57:7; 124:2; 279:20; 280:17, 18;
raises 42:6 rejoinder 148:22
190:7,21 154:23 283:16
raising 78:13; 146:2, 3; relate 20: 15; 94:2
reaching 244:18 recent 11:14; 34:14; reductions 21:17; 22:20;
147:13 5O:1O, 14;59:22;90:2; I’e[ated 22:2; 25:13, 18;
reaction 92:14 48:7; 50:20;52:11,21, 21;
Rakowski 17:9; 95:16; 119:4 ;278:10 36:2, 15; 43:7; 60:17;
read 5:9; 10:24; 89:21; 53:22; 56:8;62:15; 153:3; 165:2; 177:25; 183:18, 20;
151:8; 179:4,5,7, 9; recent-1 119:3 155:13, 14;157:8, 10;
121:4; 124:23; 146:14; 207:20; 229:13; 231:14;
181:12, 15; 187:14; recently 15:8;17:16; 172:22, 23;173:12,13
170:3; 182:12; 188:7; ;!32:5, 11;235:14
246:15,15 55:4,10;90:15; 112:12; reemphasize 161:5
254:6; 289:8 r’elates 144:24
random 115:1 116:25 reestimated 109:22
reading 169:19; 170:3 relation 20:7;93:6
randomization 96:3,6, Recess79:2 reestimated 191:3
reads 272:8 relationship 33:1; 37:1;
7, 22; 162:22; 253:8; recessed 178:5
real 112:17,22; 137:15; reevaluated 125:15 54:9; 181:18
261:9; 274:18
164:24; 211:13; 234:3; reclassified 138:4 refer 27:15
randomized 14:17; reiative 11:23; 51:23;
247:6; 277:4; 289:17 recognize 163:25; 206:4 reference 70:18,19; 52:6, 10, 11, 20; 53:7,9,
34:25; 53:6; 55:12; 68:9;
70:23, 25; 81:19; 94:12; reality 156:11 recognized 120:4; 249:20 22; 54:2, 6; 56:6; 58: 10;
95:22; 187:21, 22; 206:23; realize 89:7; 135:5; 200:16 referred 67:25; 104:1; 63:5; 145:17; 152:14;
249:22; 290:2 213:25; 227:3 recognizing 162:21 224:8 1.53:2; 157:3; 158:6;
randomly 99:2; 102:1; realize-and 191:13 recommend 45:19; t’efeRJ 83:12 1.81:23; 191:19; 216:11;
114:19; 190:23 really 7:24; 8:20; 25:20; 196:4;202:19; 252:15,17 reflect 15:21;46:16; 233:9; 240:9; 241: 19;
26:2o; 28: 14; 30:25; ecommendation 40:24; 246:25
range 11:25; 26:19; 41:4; 122:23; 270:3
50:16 ;63:12; 69:21; 33:15 ;45:1, 14; 52:17; 59:1,2,4 ;65:23;66:11; relatively 28:20; 60: 12;
reflect-1 286:5
91:18; 197:19; 201:14; 57:25 ;62:11;64:2; 68:13; 71:4;108:1, 12;116:24; 66:23
;81:14;
112:8;
reflected 191:13; 192:18 1.85:17;
186:24;
198:8;
241:1 73:25; 75:6; 83:16; 84:13; 253:19
86:6; 92:18; 101:5; reflects 167:6 237:3;
242:19
ranged 95:23 ‘ecommendations-
108:16, 19; 110:14; Iave 41:3 refrained 84:12 release 14:1; 71:14;
ranging 261:22,25
118:22; 119:18; 121:2; ‘commended 37:11; refrigerator 116:1,13 79:15; 81:22; 82:13;
rank 142:18; 153:19 125:21, 23; 132:6, 11; E16:24;87:3,7, 18; 89:9;
[1:3;
58:22;99:8;
189:1 regard 5:24; 22: 13;27:9;
Rankin 163:15 134:3;
135:3;140:2; 28:8;34:23;35:1,9,18, 95:1, 9; 143:3, 25; 144:6,
‘commending 40:20
143:4;
rapid 38:14; 80:1 1; 196:4, 144:24;146:12; 18;41:14; 42:17;
43:6; 1.5,16; 151:5 ;153:1;
147:7,
21;148:16;15?:9; ‘ecommends 204:16 1.54:4;186:14; 192:15;
24; 198:22 32:14;85:9;93:12;
rapidly 48: 13; 49:8; 156:8;
159:8;162:12; ‘econcile 67:7 139:11; 144:23;
164:23; 204:11, 22,23;208:12;
85:24; 202:21 164:9;
168:18;170:1; ‘eCord 5:25; 7:14;95:20; 204:7;206:2,14,15; :!65:6
172:10;
173:3;179:23; 121:4; 124:25; 125:18; 208:19; 209:3;
222:18; r’eleased 85:23;86:10
rare 60:5; 248:9,11
181:18;
182:7;183:16; 132:22; 170:3 237:20;271:2 releases 85:19
rash 60:13 184:5;
186:24;187:4; ‘ecorded 199:24 regarded 140:21; 189:6 relevant 27:18;145:15;
Rashid 203:18; 215:4,6;222:14,
17;228:17;
219:6,11,14, 17,23; ‘ecovery 194:25 regarding 51:10; 100:6, 149:11,11, 15;150:17;
229:21;
231:13,24;232:1;
220:5,
16,21;221:3,19, 238:9,21, 23;243:19; wcruited 14:20; 96:2; B;192:8 1,64:3;183:13;191:15;
21;222:21;
223:20;225:8; 245:25;
247:3;259:16; 123:9 regardless 15:12; 38:21; ;!24:13;244:9,11;264:7;
226:2,10,17,20,
25; 260:4,
24;261:20;271:2, ecurrent 17:4; 50:1,2; 44:13;%:11;151:19; ;!80:12
227:4,10,20,25 7;275:5;
276:10;279:3; 12:9; 198:23; 201:13 237:14 reliabil”~ 94:23
rate15:3;
55:17;
117:3; 282:13;
284:11;286:5,16, ‘ed 85:25 regards 274:12:275:9 reliable 33:13; 71:8, 10;

Miller Reporting Company, Inc. Min-u-seripti (23) question--does - reliable


Advisory Committee Food and Drug Administration
‘VOL 1, April 28, 1998 Peripheral & Central Nervous System

140:3; 160:14 279:4 5, 23; 219:20; 220:17; 200:10, 17;201:13,17,19,Safety 11:10; 15:1; 17:8;
-relied 73:12 rSqUiring 205:8; 288:4 221:11; 225:25; 237:8; 23;202:2,7, 12;204:17; 26:16; 35:18;66:6; 94:25;
s~ieVing 280:3 rerun 107:12 243:18; 260:19; 262:16, 206:14; 208:4; 210:3; 97:20;98:1,5;99:15;
25; 276: 1; 279:2; 286:8,9; 216:4, 15,22; 217:1, 15, 100:1,7;101:9,9, 23;
33:17;
243:18 Research 6:5, 19; 12:5;
289:1,2, 6; 290:18 21;225:12;229:7; 231:7; 102:7,12;103:6,13,17,
relying 36:20; 244:2 16:17; 40:6; %:4; 194:21;
reSUitS-Up 125:25 241:14 ;242:18;254:13, 18;104:3,11, 16;105:13,
remained 210: 10; 240:17 195:23; 1%:14, 15, 17;
198:16; 199:15; 236:3 resume 177:23 15,19;257:9; 275:4; 23;106:7, 18;113:12;
remaining 84:2; 197:1 5; 280:17, 18;283:5 115:15;131:19,19,22;
researchers 195:25 resumed 178:5
257:1 risks 200:6,8 132:2;179:6,10,12, 14;
reservation 292:17 retinal 141:15
remains 11:4; 92:25; Rob 39:12; 72:25; 77:8; 180:1;185:15; 186:12;
retired 9:14
115:14; 144:17 residents 256:4 187:2,12;192:5; 252:20;
retrieve 139:6 118:9; 171:9; 233:22;
remark 164:23; 187:20 residing 200:9 265:23; 282:24; 292:14 253:9;2 74:12,14
retrospectively 232:24 sake 234:9
remarkable 180:20; re$ized 233:8 Rob’s 168:22; 169:9
182:2 returning 8:25; 9:6 SALT 56:4,9
resizing 261:8 Robert 6:18; 167:4
reVerSed 242:9
remarks 17:10; 191:18; resohre 48:13 same 22:l;32:12; 43:21;
reversible 60:5, 7; 86:3; ROBIE-SUH 4:20, 20;
222:6 reSOhfSd 78:16; 188:10 126:18,19;127:11;203:6, 59:4; 68:20; 76: 11; 81 :2o;
87:11 ;89:4 63:13 ;91:12; 93:12;
remember 71:24; 127:7; resources 194:14 9,13;209:19;218:13;
130:5; 164:8; 174:2 reVet’t 234:23 95:25; 97: 12; 106:20;
re$pect 7: 15; 27:13; 225:9,10
remember-maybe review 13:16; 17:6, 19; 116:4; 118:6; 120:20;
57:2; %:7; 115:10; robust 15:12, 21;72:5; 126:11; 127:2; 134:16, 19;
174:1 30:13, 14; 98:5, 14;
165:13; 210:3, 21; 224:5; 129:14; 130:24; 203:18, 119:22; 147:24; 154:7;
139:13; 150:21; 153:19,
remind 123:25; 197:8; 260:11, 13; 262:9,12 192:8; 254:24; 289:24;
19;215:5,7; 219:24 ;220:4 20; 155:16; 157:22;
264:19; 266:20,22 290:19
respectively 153:3,5 reviewed 8:16; 98:20, 25; 159:12; 166:1, 13;171:6;
reminds 8:22 robustness 119: 17;
respond 29:19, 22; 99:1; 108:7; 141:9, 9; 175:21;
191:3;193:6;
renal 183:7 162:7; 191:9 123:10; 124:10; 139:4; 208:16;
216:12;217:5;
260:7; 277:22
Rep 4:14 reviewer 284:8 141:23; 142:3; 150:10; 218:9;
219:2,21;231:5;
responding 31:15;
repair 80:12 153:15; 159:21 234:2;
239:18,21;240:19,
278:21 reviewing 102: 12;
repeat 20:9; 56:24 role 36:18; 101:5; 150:2; Z4;251:15;
274:2;291:23;
response 26: 15;29: 14; 137:18 292:2,2
repetitively 275:12 244:14; 276:7; 277:1
30:24; 32:18; 33:21, 23; reViSSd58:16
Room 6:13; 112:16; sample 31:3; 44:1, 17;
replacement 205:1 34:1; 80:1 1;90:6; 92:17; reViSing59:6
101:24; 108:14, 15; 116:9; 116:8; 202:25; 272: 11; )7:11, 11;106:24;107:11;
replication 148: 13; 244:7 rewed 64:20 ~08:11,
18,22,25;109:5,
143:24; 187:13; 193:19; 282:7
,_#-~Ort 98:15; 114:22; rewriting 271:16 ?2;110:3;
111:1,7,17;
203:2; 209:18; 245:9; root 263:14; 2647,8
21; 163:19; 164:18; Rhode 16:11 113:17;
120:2,5,8,14;
252:1; 265:17, 23; 268:21; rough 152:9
., J:12; 176:3,8; 188:5; 121:2,7;,122:1,2,21,23,
269:9 Richard 4:15; 6:10; 9:6 roughly 26:9; %:17, 23; ~4;123:6;
125:10,13,15;
190:2, 4; 217:25; 226:12;
247:25 responsible 98:10; Ridker 26:22 151:24, 25; 152:7, 7; L26:20,
;22,
25;127:8,13,
179:9 right 7:20; 36:21; 39:6; 154:4; 155:16; 157:8
reported 6:3, 6; 24:12; [3;131:7;
189:21;191:3,
51:22; 53:7; 212:25; ‘est 20:3; 44:20; 262:3; 44:7; 45:17; 54:15; 57:7; roundabout 232:6 (;220:10,
12;226:2,3,8,
238:16 273:9 59:7;69:16, 17; 72:8; routine 177:7 12,15,18,
22;227:15;
‘estate 158:24; 270:11, 77:14; 78:1 1;79:4; 83:17; !28:1,2,
2,3,8,10,13;
reported-of 172:6 routinely 113:16; 130:24
25 34:17; 91:20 ;98:21; !38:11;
261:23;275:25
reporting 24: 15; 180:7 105:20; 111:15; 115:8; row 217:6
‘estaurant 178:2 tample!s 67:14; 227:23
reports 97:20; 100:22 123:22; 127:18; 129:23; Roy 9:1
‘eSting 133:16 landra 5:20; 78:18
represent 82: 18; 84:2 130:10; 138:5; 164:5; rubric 105:13
‘restrictive 259:11,17 170:25; 171:21; 173:5; iat 117:14
represent-you 71:17 de 11:18,22; 92:20;
‘ests 247:6 176:13; 177:15; 182:13; ;at isfactory 275:17
representation 31:18, 125:1,
20;130:23
‘esuit 22:10; 37:5; 44:16, 187:15; 225:7; 227:18; ;atisfied 44:20; 292:15
18 wlernaking 11:15
L8,19;93:7; 113:22; Z28:1;232:2; 233:6; ;at isfie:s 160:15
representatives 200:1 Z37:19; 242:17; 248:20; ‘Lde$ 5:2; 99:10; 100:13,
116:3, 16; 117:22; 118:21;
representing 199:9; Z49:lo; 255:6; 256:14; 16; 105:15; 106:9; 110:16, iave 72:6; 75:9
[20:19; 150:7; 151:21, 22;
225:4; 288:4 ~57:5, 13, 19; 264:23; 23; 111 :22; 130:6; 247:16, ;aved21:13;156:16
[57:18; 161:13; 163:16;
~o ;aw24:13;28:14;89:lo;
represents 71: 18; [65:1; 188:2; 202:15; M8:7, 19, 22; 269:4;
191:23 !05:21; 218:14; 240:18; ‘ules-and 121:24
171:8, 15;273:18,21, 23; )3:12;
133:23;136:1;
reproducible 15:12 !42:16; 258:24; 261:4,8 !81:17; 291:16 ‘un 274:8 57:19;159:2;
161:5;
request 6:12; 18:24; ‘esulting 182:23; 188:9, ‘ights 146:16 ‘unning 171:18, 19 !08:22;
276:25
129:10 [3; 198:12 IIND 188:15 runs 80:13 ;ay-1286:14
requested 103:8; ‘eSU!tS 8:17; 12:3,14; ‘isk 10:20; 11:5, 19,23;
‘upture 92:15 ;aying 29:20; 39:1; 41:6;
121:25; 176:3; 252:16,18 15:11,
14;19:19,23; L5:1;
18:10;19:21
;26:13; ‘uptures 47:10 [3:22; 44:13, 15; 58:8;
require 14:5; 136:18; !0:10;
30:9,17;55:16; !9:16,
17;41:20;
42:8; ;5:2; 69:9; 98:1; 102:9, 24;
?ush 4:16 .25:19; :131:3;170:2;
155:5 ;3:
10;82:3;
84:9;86:20; ;0:20;
51:23;52:6,
10,11,
18:2,
22;94:22;98:17; !0;
53:7,9,22;54:3,6; +USS 4:24 !20:16; 231:10; 234:7, 12;
required 60:10, 22;
,04:23;
105:20;109:18; i6:6;
57:3;
62:15;63:5; !35:3; 237:7; 238:14, 17;
~7:25; 135:11, 17;
“— “’:16;215:14
#irement 146:20;
.11:8;
115:4;
.20:13;
117:21;
139:10,13;
S:23;76:1;
[48:21;
92:4;
152:14;
94:5,5;
153:2,7;
s !51:5; 2!55:18;256:1;
!61:19; 263:9, 23; 264: 17;
.41:24;
142:5,17;150:4, 154:13;
155:14;
156:2,3; !70:16; 271 :3; 278:24;
160:24 1,
20;153:19,24;154:6, 5AEs 185:1 !84:4, 6; 285:16; 287:22
157:3,8,9,
10;158:6;
requirements 15:24; .6;155:13,25,
25;157:17, 159:3:160:11:184:2: ;afe194:23;
196:3; ;cale 163:15
160:15; 192:10 8;160:24;165:8;166:15; :94:16; 195:10, 21; 196:5; !05:7;
290:11 ;can 134:6,6; 135:19;
requires 136:6; 159: 17; 67:6;203:17,18;2073, .97:19, 23; 198:3,4,6, 11; ;afer 66:24 76:17; 182:7; 188:24;

relied - scan (24) Min-u-script’cl) Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
Peripheral & Central Nervous System Vc~L1, April 28, 1998

189:4, 5,8; 256:5,22, 25; 206:10; 229:21; 21; 149:17; 150:9; 154:14;
224:18; 111:22; 145:25; 152:17; [32:4,6, 10; 89:14; 97:11,
257:3 236:15;240:19; 18; 165:18; 166:23, 25; 167:7,
248:7, 153:4,12, 18; 154:7; :11;106:24; 107:11;
Scandinavia 218:16 280:20 12; 169:20; 170:8, 18; 156:3,4; 157:1, 5,8; :108:11,18,22, 25; 109:6,
—. .
..—-
scans 162:15, 18; sensitive 141:25; 159:15 172:2,3,17, 17; 175:24; 158:7,12,17,19, 25; 22; 110:3; 111:1,7, 17;
163:23; 177:17; 256:16 separable 288:5 176:1; 180:6; 181:17; 159:21,23; 165:1,14, 15; :113:17; 117:21; 120:2,5,
scenario 112:4; 145:13 183:22; 190:12; 191:17; 166:25; 173:10,14, 15; :14;121:2,8; 122:1,2,21,
separate 23:5; 30:3; 23, 24; 123:6; 125:10,13,
207:5 ;210:14;211:18; 183:2, 10; 185:18; 195:19;
scene 84:22 57:23; 64:14; 112:18;
212:12; 235:13; 260:19; 205:7; 210:17,19, 24; :[6; 126:20,22, 25; 127:8,
schedule 177:21 139:9; 168:15; 211:4;
268:24; 269:2; 276:1 1; 211:9, 19,24; 212:21; 1[3,13; 13012; 131:7;
schema 25:21 244:21, 22; 267:19, 20; 1[55:16; 189:21; 190:17;
287:22 213:6,18; 214:5; 215:23;
281 :24; 287:21 1[91:3,4; 220:10, 12;
schematic 80:5 showed 12:2; 34:12, 15; 221:11 ;225:1;231:23;
separately 120:19; 226:2,3,8, 12, 15, 18, 22;
Science 16:13; 191:11; 54:22; 69:15; 82:8; 88:14; 235:17; 236:20; 241:18;
244:21 227:15, 23; 228:1,2,2,4,
291:19 130:5; 148:25; 153:2; 278: 15; 285:23; 286:25;
sequelae 188:11 290:3 8, 13; 233:4, 12; 238:12;
scientific 14:10; 41:10; 156:12,21 ;159:3; 167:1; 239:24; 261:23; 275:25
193:5; 275:2; 279:8; serious 11:2; 93:17; 211:11; 222:4,10, 17; significantly 15:4; 35:5;
291:12,13 184:16,19, 23; 186:22; 224:10,11, 12;246:11; 43:15; 44:18; 59:17; 72:2, $iZed 21 1:3,4; 232:25;
195:9; 214:21; 254:25 260:11; 276:25; 290:17 5, 19; 160:10; 192:15; ;!33:2, 3
scientifically 33: 11;
41:14 ;65:5 seriously 262:19 showing 20:20; 34:9; 199:21 ;201:24; 275:12; dZtMi 31:3; 67:14; 240:11,
64:5,6; 65:13; 68:19; 71:8, 285:25 11
scientist 40:9 serve 9:3
10, 13; 109:17; 159:11; signification 190:6 ukeptical 36:20
SClerOSiS 250:22 service 9:9; 195:22
169:11; 170:12; 187:23; signify 268:23 skepticism 250:23
screen 150:11 set 69:14; 70:1; 117:18; 210:16; 240:19; 288:25 signs 137: 1;188:23; !davishly 283:11
screwy 234:4 121:5; 124:25; 136:7;
shown 15:25; 18:18, 20; 201:6 !Nide 10:13, 17; 11:17;
scud 118:18 236: 14; 247:20; 258:8;
19:15; 23:14; 33:24; 38:7; sildenafil 90:15, 18 1.2:22; 13:3,11, 17,21;
284:10; 285:10; 286:19
se 287:7 39:24; 41:4; 44:17; 50:2, 1.4:22; 15:10,19, 25; 16:1,
setting 68:6; 109:4; Silly 77:18
Seattle 4:7 12; 51:4; 55:22; 59:24; 6,15, 25; 20:18,19, 20;
280:3; 291:6 62:12; 66:1; 67:21; 81:7; silly-but 168:9
second 12:12, 13;18:15, 21:1, 1,5,7; 30:1,2;
sattle 244:16 87:24; 157:11; 159:1; similar 23:20; 29: 19; ~4:20, 20; 46:4; 47:4, 21;
25;94:23; 128:13; 143:15;
160:9; 161:3; 167:2; 36:19; 48:10; 60:18;
150:12 ;192:14;204:1; settled 171:22 4i8:9,17, 23; 49:11, 21;
174:12; 207:13; 210:13; 66:16; 83:1; 155:14, 20; 51:2, 8; 53:4, 18, 19;
217:6, 18;218:22 ;219:5; seven 77:4; 268:25;
216:4; 221:7; 258:2, 15; 181:13; 219:23; 285:10 54:11; 55:2; 57:5, 22; 58:1,
260:10;267:9; 268:1,17, 269:3
18,19 260:22; 263:13, 16; similarity 180:7,20, 25; 13, 24; 59:9; 60:16; 61:14,
several 26:20; 30:6; 31:5;
264:18; 270:5; 275:5; 181:3, 8; 182:2; 184:8,10, 1.5;65:3, 18; 66:18; 67:18,
.- secondary11:11; 13:6; 55:7; 90:19; 110:12;
277:9; 287:24; 288:5, 10; 13 ;!2, 23; 68:8, 12, 15; 70:3;
66:20; 79:16;133:7; 113:13, 15; 169:16; 197:4;
292:12,23 similarly 24:25; 91:12; !10:3,15;81:1,6,7; 82:2,
141:7; 150:11, 16;155:9; 200:21 ;215:18; 233:9
173:11; 191:24; 193:9; shows 22: 15; 47:22; 143:8; 156:3; 158:7; 216:2 3, 15; 84:18; 85:7, 12,20,
severe 47:6; 48: 12; 60:4;
196:16, 19;197:9; 198:10; 173:24; 174:15,16, 18; 67:23; 68:16; 75:6; 82:13; simple 144:9; 236:5 ;!1;86:1, 22; 87:9, 23;
201:11 ;202:6,12 148:4, 21; 190:16; 213:5, 5~4:20;95:18; 96:1,15, 18;
258:6 simply 44:10; 84:22;
23; 249: 17; 285:20; 286:8 97:1, 10; 124:17; 130:5;
Secondly 26:11; 28:13; severely 174:17 %:16; 107:20; 114:20;
Sid 6:10; 279:25 145:7; 190:25; 262:25 132:20; 133:6,19,21,22,
223:9 severities 174:4
side 12:19; 26:21; 27:8, simulation 107:12 25; 134:1,3,4; 139:4,8;
seconds 195:6
severity 173:23; 174:6; 10;34:1,1, 17,23; 35:1, 141:4,5, 20; 142:10, 22;
secretary 5:21 182:23 simultaneous 254:10 148:8; 149:19, 20; 150:3,
14;38:4, 16;40:11; 41:8,
Section6:9; 7:2;74:15; Sex 188:17 ;210:3 15,25;42:12, 14,18,23; simultaneously 5:4; 2!3;151:20; 152:10, 22,23;
289:7 60:5,9,12, 14;65:10; 59:3 153:14, 25; 155:8, 10;
shabby-l 225:3
seeing 88:20; 99:12; 66:7, 8;93:8; 98:14;99:12; sincere 17:12 156:7,13,20, 24; 157:6,
shall 46:25; 78:21
158:16; 236:9; 250:18 136:23; 187:20; 214:10; single 15:24; 62:1; 69:11; 15; 158:9, 22; 160:7;
share 26:14; 45:9; 84:22; 165:18; 170:10; 176:6, 14;
seeking 165:20 237:1 1;247:12 73:14 ;78:11; 160:16, 18;
129:1; 169:9 179:8,11, 19;180:12,13;
seeks 10:18 sides 140:5; 276:16 192:10; 204:1; 205:14, 22;
sheets 252:4 206:2,9, 17; 208:7,8; 181:20;182:7,9;183:1,4,
seem 46:3; 163:7; 167:9; sight 279:14 12,24;184:3,15;185:21;
Sherman 16:11 ;89:1, 3 209:23; 218:13; 219:17;
182:5; 190:10; 274:19 sign 136:19; 137:4 186:10,15,21;188:4;
shift 174:1o 222:6; 224:10, 11;231:22;
seemed 94:lo; 191:1; signal 5:6; 88:12; 169:13; 189:11,18,22,25;191:8,
short 12:10; 49:23; 55:8; 242:20; 243:10, 18;244:2,
278:18; 292:15 249: 17; 277:20; 284:20 7;245:20; 252:8,9, 25; 7!2;
192:4,12,17,23;
109:16
seems 18:19; 77:13; signature 15:4 261:23; 2 65:7; 2 68:5; 193:7,11;203:11,20;
88:21; 93:6,8;106:17; short-term 55:23 2!04:9;
205:2, 13;206:5,
significance 15:3; 57:7, 275:10;279:10;284:7
110:22; 124:24; 140:8; shorter 137:17 2!1;
207:1,6,18,24;208:6,
15;99:14; 126:11; 132:9; Sit250:20; 288:1
145:11; 166:3; 181:6; shortly 79:14,22,23 155’7; 156:22; 157:17; 18;209:2,13;210:5,12,
190:25; 228:17; 251:23; site 80:1; 1 77:13;206:23; ;!0;211:6,
10,11,16,20;
should-l 2;9:20 173:16; 183:22; 185:16,
258:25; 267:17;286:7 221:16; 242:18; 246:2,4;
shouldn’t 39:12; 69:10; 20; 186:23; 211:3; 215:15; 212:4,10,17,23;213:4,9,
261:10 16,22;214:2,9,20;215:9,
SSSS 239:15 119:1; 126:25 219:1, 9; 220:20, 24;
sites246:7 16;217:7,23;218:12;
segment 78:20 show 15:23; 16:2; 19:20; 229:20; 239:18, 23; 241 :6;
245:2 situation 18:14; 22:1; 2!21:6;
249:19,23,24;
seizing 289:14 20:18; 22:10; 27:15; 31:3,
75:4; 77:22; 109:2; 250:16
.-. Se[eCted 50:16; 87:20 5;34:13; 35:13; 39:18; significant 13:7; 14:23;
123:15, 19; 165:5; 227:19; slides 18:8; 21:3; 27:16;
seminal 27:5 i2:13; 52:17; 54:17; 15:11; 19:10; 22:8, 10;
243:19; 280:23; 291:11 67:8; 75:25; 123:24;
52:15; 63:10; 64:22; 37:4; 44:14, 18; 54:18;
Senior 10:5, 14; 194:5,10 Sk 58:15; 60:10; 149:22; 124:10; 180:6
73:23; 75:13; 88:14; 55:19,24; 57:12, 17;
sensation 176:13 108:18; 109:12; 123:21; 61:12; 67:16; 69:5; 71:2,8, 175:17,20 slight 118:13
sense 111 :3; 147:8; 124:11, 11;129:20; 139:2; 10; 72:4,16, 17; 73:10,13, Sixth17:17 slightly 21:12; 62:21;
172:11; 179:23; 185:16; 141:24; 146:12,21; 147:9, 19:91:9.18:93:18:
..- size22:5:43:6:44:1: 2!24:16

Miiier Reporting Company, Inc. Min-u-scriptra (25) Scandinavia - slightly


Advisory Committee Food and Drug Administration
VOL 1, April 28, 1998 Peripheral & Central Nervous System

small 27:4;
31:20;44:5; 132:3;
136:2,10;140:7; 227:4;245:10;
251:25; 110:2; 114:23; 120:14; 16
48:4;52:17;
67:13,17; 145:8;
148:19;163:9; 252:9,12;255:1,2;
262:8; 121:21,24; 125:4; 128:7, strike 163:3
~#Q;81:14;112:5,17,22 164:4;
172:7;221:24; 279:10;280:16 24;129:11 ;215:4; 238:15 striking 26:20; 170:20;
9;114:1;118:11; ‘ 225:22;
227:1;228:21; sponsor’s 169:5 statistician’s 190:4 172:5
.:23;
148:25;
155:18; 229:6,
9;230:5,6;231:10;
sponsored 12:8 statisticians 74:22; stroke 10:21, 22; 11:1,2,
156:22;167:7;
169:6; 232:6;
237:1;242:16,
20;
sponsorship 201:5 105:12; 107:9; 118:12; 14,19,20, 24; 12:2,3,9,
185:3,9;208:17;
210:10; 243:23;
244:12;249:4; 132:1; 227:5; 229:5
229:23;242:3,
19;248:20, 292:3 spuriously 235:16 13, 25; 1,3:2,6; 14:19, 25;
statistics 125:21; 166:3 15:2,14,15, 22; 17:4,15,
21;280:13 SOrtS89:9 stabilized 97:4; 188:24
Stay36:13; 116:12; 127:2 18, 20; 1.8:10,12,14,17,
smell-scale68:9 sought 204:19 stable 38:1; 88:19;
steering 108:1, 3;125:8, 19, 21; 1,9:8,17, 22; 20:7,
smaller113:5;124:6; sounded 221:23 188:20 14; 22:9,10,15, 20; 23:2,
11;127:5
172:16;238:20;
239:15, sounds 76:16 staff 8:15 10,14,1.5,16,17, 17;
stems 197:10
24;240:11,20;
241:16 source 50:18 staggering 197:11 24:15,20,20,21,22, 24;
stenosis5013,16,22 25:12,12, 18; 29:10, 13;
Smart 195:22 South 199:24 stand 160:25; 290:12
step120:21; 257:25 30:9; 31:4, 24; 37:7,13,
smattering 46:20 Southeast 201:23 standard 74:9; 103:7;
stick39:13, 15;75:5; 15,25 ;41:19;42:3;45:18,
smoking 200:12; 201:18 Southeastern 199:20 135:7; 205:16; 223:7;
106:20; 112:6; 116:20; 20, 25; 46:6, 8; 47:5, 23;
SOCiety 11:7; 198:1 Southern 4:13; 218:17, 229:20 117:6; 289:7 48:10,18,22, 24; 49:2,6,
softer 139:20 20,22, 25; 219:3; 221:3; standards 129:15 $tiil
8:12; 24:23; 42:6; 9,12,14.,16,19, 23; 50:1,
solvable 251:8 247:10 standpoint 74:8 44:12; 73:16;84:1; 93:25; 4,6,7,10,10,14,19, 20;
space 47:12 Stanford 17:3,15 104:21; 107:23; 133:4; 51:4,5, 11,17; 52:1,3,9,
somebody 24: 17; 56:17,
Spain 247:10 159:20; 163:22; 164:3; 18; 53:2, 5; 55:7, 17;
18; 57:13 ;67:18; 135:11; start 4:5; 21:4, 5; 34:3,3;
170:25; 173:10; 185:20; 57:18; 58:20, 21; 59:5,11,
140:23; 166:6; 175:5, 7; spared 152:4,5 38:10; 79:1; 80:1,10;
192:25; 206:24; 207:20; 12,16,18,18,22,25, 25;
227:16; 233:21; 258:22; sparing 152:7 B1:25; 113:12; 150:6;
220:22, 23;225:18; 60:25; 61:2,9, 17; 62:2,6;
282:2 speak 5:3, 6; 167:4; 179:4; 180:13; 184:17;
228:24; 237:19;242:6; 63:2,4, !);64:8; 65:21;
somehow 238:12 172:10; 196:20; 202:23; 234:7; 242:15; 252:24;
253:10; 260:21; 290:15; 66:1,21,25; 70:22 ;71:14,
243:6; 284:11 261:3; 262:6
someone 75:14; 98:4; 292:1 16,20,23, 23; 72:1,3,7,
126:23; 265:2; 269:13 speaker 16:7; 215:7 started 5:2; 117:1; 13,14,16,20, 21;73:8;
stimulating 9:4
175:10 74:18,24 ;75:15,21; 76:1,
someone-Rob 278:3 speakers 17:2 stoke11:12
starting 108:24; 233:24 13,18, 23;77:14; 79:17;
something 20:6; 43:2; speaking 5:12; 130:22; stomach 36:1
starts 80:2; 181:23 80:2, 19;90:25, 25;91:13,
72:11;75:3,9, 16;77:5; 143:19; 163:1; 164:5
stop78:21; 101:1; 17; 92:1, 4,9; 93:13, 20;
~6;99:12; 100:8; special 55:22 State 149:3; 231: 16;
110:23; 126:23; 130:15; 94:5, 23; 95:3,4,7, 9;
15,16;111:24; 286:7
SpdfiC 22:6, 18,25; 160:9; 214:18; 219:5; 96:24; 97:3, 5; 99:6;
..22; 127:25; 130:18; 25:5; 28:23; 29:21, 23; state-based 200:21 254:11 101:25; 103:24; 104:14;
138:12; 146:16; 148:8,9, 32:2, 8;52:18; 53:17; 55:5; stated 58:14; 142:13, 14; stopped 99: 13; 173: 1; 105:16, 24; 108:9; 112:2;
14;149:10; 161:16; 66:13; 95:5;145:16; 156:8; 260:6; 270: 10; 241:25 115:4; 119:13,24; 124:19;
169:14;170:8; 176:22; 184:6; 188:18; 203:24; 271:18
StOpphIg 99:8; 100:4; 125:4; 1:26:1,2; 128:2,4,
224:12; 225:22; 235:11, 224:6; 235:15; 244:6; Natement 5:20, 22; 105:14; 106:10;125:1; 4,8, 13,15,21; 129:9,18,
14;236:12; 237:8, 10; 263:7, 23;266:10;284:10, 30:23; 43:4; 171:12; 130:11,23 20; 130:17; 131:13;
243:22, 25;251:19; 256:7; 14 190:4; 197:6; 287:6
store85:19 133:16; 134:12,13,15,15,
266:5; 269:22; 279:18;
specifically 29:5;31:25; Statements 6:12 19,22, 25; 135:8,12,16,
281:23; 287:24; 288:2; stored85:17
50:12; 52:3,5;53:3; states 28:24; 48:21; 49:1, 22; 136: 10; 137:8,19,24,
291:19,22 BtOry 106:15
117:15; 125:9; 152:21; 14; 195:5,8; 199:20; 25; 138:4, 18; 139:17, 23;
SOIIIetimS 135:20 168:18 ;275:11 straight124:25;
142:20 140:12, 12, 17; 141:18;
WO:1O,14; 219:19;
sometimes 5:15; 24:2,
3; specification 120:10 straightforward
65:22 142:8; 148:21, 22; 150:8,
?75:22
112:14; 115:23; 126:24; 14,20; 151:15,18,25;
specified 18:14; 123:13; Stating 272:2 Strange 166:17
161:21,24 ;205:21;207:7; 152:4; 1’53:18; 154:3,4;
125:1, 20; 132:8; 150:16; Natistical 15:13; 57:15; Btt’St(@X?i 198:2, 10
214:14; 257:15; 279:21, 155:11,16,23,24,25;
204:4 77:21; 99:13; 106:16; strategy 21:25
21 156:10,11;157:14,16,18,
Sf)eCify 100:12; 129:13; 128:11; 142:11; 143:2;
somewhat 7:23; 20:21; SWStifikd 153:20 19;158::23;
159:8,12,13,
226:23 157:17; 165:20; 173:15;
120:25; 124:6; 146:3; Street 17:9; 19:17; 20:17, 13,19,
22;160:11,12,18,
speculate 89:8 183:22; 190:5; 203:19;
150:4; 151:4; 180:13; 25;88:4; 94:18, 21; 97:17, 18;161:15;162:17,19,20,
~08:21; 211:2 ;215:5,7,
204:3; 232:23; 240:12; speculating 235:21 20;98:4; 102:18; 107:10; 25;163:16,20,25;164:12,
253:11; 264:24; 265:2; 14;220:20; 226:13;
speculation 92:11, 25; 229:10, 20; 230:25; 232:3; 114:17; 115:11; 122:24; 19,21,21,25;165:2,3,
279:7 93:2; 109:3,6 123:24; 124:13,18, 22; 16;166:11;167:17,20,21,
Z39:18; 243:9; 247:6;
somewhere 69: 14; speculations 119:11 127:4,16, 20; 128:3,7, 10; 25;168::3,
4;170:13,14,
284:8 15;171:13,15,18;173:13,
233:14; 255:2; 264:18 spend 131:7 129:5; 132:16, 17; 133:10;
Natistically 35:5; 54:17; 138:19, 25; 139:3,18,22, 21,23,23;174:4,6,14,
soon 78:20 spending 284:6 55:19, 24; 57:12, 17; 25; 141:3, 6; 143:17, 25; 16;176::2,8,10,15,
24;
sorry46:13 ;83:ll; spent 129:11, 12 59:17; 61:12; 67:16; 69:5; 144:18; 149:19, 20; 177:2,
1:2;182:15;184:22;
97:15; 125:14; 129:22; spirit 230:4; 232:13 71:1;91:8; 156:25; 157:8; 186:23;187:21;188:12;
154:12, 17; 155:3, 9;
134:23; 177:3; 247:2; 158:12, 17; 160:25;
spite 11:5; 291:5 159:7,10,14, 23; 187:5; 189:13;190:15;191:24;
&Q20; 273:5; 282:1 185:18; 207:25; 210:17;
Split 45:3; 129:6 189:24; 190:1 192:14,19;193:9;194:6,
‘y--i 225:3 211:18;212:21;213.6; 10,12,13,14,15,16,19,
spoke 168:19 strength 149: 10; 237:2
-A 8:2; 25:11 ;33:15; 222:16; 240:17; 242:6; 19,20,24;195:1,3,5,5,7,
285:23,25 strengthens 207:14
36:20; 39:9; 56:14;67:4; spoken 284:9; 291:2 8,9,10,11,16,17,18,21,
73:14, 21;74:1, 12;78:3; sponsor 5:7; 16:4; 24:1; !itatistician 98:13; 99:16, rdreptokinase 148:11
22,24;196:1,5,9,13,16,
93:15; 105:11, 18;106:8; 116:1o; 138:16; 193:18, 22; 100:14; 104:2; 105:6; strict 144:11 17,19,20,22,23,25:
117:13; 127:1; 130:6; 20;21013; 212:5 ;216:4; 107:24; 108:12; 109:7; Strictly 143:19, 23; 148:3, 197:1:2,,3,5,6,7,10, 10,
——
small - stroke (26) Min-u-scripl@ Miller Reporting Company, Inc.
Food and Drug Administration Advisory Committee
Peripheral & Central Nervous System VOL 1, April 28, 1998

12,14,16, 19,24; 198:1, 245:5; 246:13; 247:5, 23; 226:9, 22; 232:14; 238:6, suggested 12:6;
25:14; 257:16
3,4,4,5,10,18,19, 23; 248:16, 25; 255:22, 25; 8,10, 22; 240:12, 16; 39:12;
41:12;251:17; surrounds 106:6
199:2,7,9,12,13,19,20, 256: 13; 274:24; 289:1,3, 241:24; 243:18; 244:2, 7; 270:3;276:6;
287:6 survay 201:7
23; 200:9,9,10,17,17, 25 245:13, 20; 247: 19; 249:2, suggesting 37: 12; 40:7;
19,20,23,24, 25; 201:3, 4; 252:9,9; 258:22; 259:6, survival 142:16; 151:23;
strong 74:24; 100:7; 93:25; 278:14
6,7,8,9,11,13,14,16, 156:14; 167:7; 172:3, 10;
158:5; 161 :6; 166:6; 9; 260:3,19, 22; 262:22; suggestion 19:3;
17,19,21, 23; 202:1,3,7, 263:24; 265:21; 266:24; 175:21, 25; 190:5,9, 19;
223:1; 237:4,13, 18; 254:18; 264:16; 281:5,11
12,13,15, 18;204:18, 18; 268:5; 274:15; 275:10; 215:20; 216:19, 25; 217:4,
291:21 suggestions 276:23
208:5,23, 24; 209:5; 276:9; 277:9; 279:10; 16, 22; 274:1
stronger 237:17; 243:25 suggests 110:5; 119:5
210:4,14,15,18, 21,24; 280:4; 281:2; 287:11 survive 161:24; 196:6;
strongly 130:1 5; 188:25; sum 67:14;69:1; 280:7 197:15
211:2,5,17, 22,23; 212:1, stuff 239:9; 243:20; 272:6
195: 1; 200:4; 220:1;
1,1,2,6,7,7,8,9,9,14, stupid 64:21,24 summarize 62:24; 79:14; SUWiVSd 37:24
284:20
15,16, 18,20; 213:15; 95:21; 179:20; 215:6; survivors 194:15; 195:7,
struck 181:9; 223:18 sub 143:13
214:1; 215:17, 25;216:7; 252:23; 261:2; 292:22 8; 198:19
217:8,12,14, 15,20,25; StrUggle 228:21 subarachnoid47:12
summarized 153:17 suspect 33: 1; 57:9
218:1,4 ;219:21;220:2; struggles 230:20 subcategory 211:21,23
summarizes 82:3; %:16; suspected 259:9, 15
221:8, 9; 222:13, 18; struggling 116:21,22 subcomponents 231:19 133:23
223:15; 224:25; 225:5, 11; subdivide 207:15 SWSpiCiOn 132:5
stuck 132:7; 261:20 Summarizing 155:9
226:4,11, 13;227:7, 12; subdivisions 207:16 sustained12:19;14:1
228:1,12,14,24, 25; studied 11:13; 13:4, 15; summery 34:20; 66:19;
subgroup 62:5; 63:4; swallow38:23
39:9, 18; 40:1; 43:20; 87:10; 139:3; 165:18;
229:3,12,13,15,22, 23; 123:9; 142:4,7 swamps 70:12
170:7; 190:4; 217:25;
230:15,19, 23;231:1,5, 59: 14; 73:3,17,22, 22;
subgroups 61:9,11, 13; 220:5; 249:24 symptom 134: 19;
14,17;232:2, 5;233:1, 22; 153:20; 202:5; 259:12;
142:1, 9; 161:2; 219:15; 136:19; 137:7, 7; 250:14
234:6,10,11, 20;235:8, 261:12; 275:21 summation 284:22;
studies 26:3; 27:23, 25; 241:1 286:6 ‘SymptOmS 37:24; 42:4,
11,12,14, 16;236:17;
237:9; 238:6, 8;239:3,6, 28:2; 31:5; 32:9; 36:7; subject 81:24 super-additive 143:14 ‘5,20; 48:13, 13; 176:12,
9,20;240:20,23, 24; 40:7; 45:7; 50:2; 51:15, 15; subjects 58:19 SUperiOr 14:15; 72:2; 15; 189:2
242:5, 16;244:20; 245:15, 52:2, 2; 53:23; 54:1; 62:22; submitted 6:2; 196:3; 79:18; 84:19; 87:25; synergistic 237:5
16,17, 18;246:1,2,4,10, 67:16; 68:6, 10; 70:9, 22; 205:14 ;208:10 88:13; 157:23, 24; 192:15; Syntex’s 6:16
10,12;247:4,11,15, 18; 71:6; 73:12; 77:17; 84:8; submitting 6:12 207:13; 285:20; 286:9
system 291:7
249:3, 13;250:2,13, 22; B9:14; 104:25; 112:25; superiority 14:24; 15:1,
subsequent 93:24;
251:19; 253:6,17,17,20, 148:25; 157:13; 172:16; 180:6; 198:7; 201:13; 13, 22; 92:23; 193: 10;
22;254:8,16,17,19, 20; 202:5; 206:2; 207:7, 8;
208:9; 228:16; 240: 13;
25610 205:1 1; 238:24; 239:20 T
255:2,5,7,17,19, 20; SUppk!d 134:5,6,7,8
243:20; 244:12; 258:18; subset 44:18, 19; 210:15
256:2,6,10,19,20, 24;
259:3; 262:15, 21; 265:24; subsets 118:5; 207:2; SUppOrt 10:24; 15:24; leble4:4;5:5;
9:13;
257:2,9,11,14, 16;
259:10,15, 16;260:9; 270:4; 275:5,7,16, 20; 219:7 34:20; 105:5; 161:23; 109:18;
114:19;
158:14;
162:6; 192:11, 13; 196:24; 169:11, 16;
18;170:12,
263:13,15,20, 24;266:11, 279:1,5; 292:6 substantial 11:8; 60: 19;
157:19; 169:7, 8; 174:19; 222:1 1; 243:24; 249:21; 185:25; 210:6; 277:22;
19;268:6,9,10,12,13, study 6:16, 22; 12:10, 13,
198:4; 205:16, 17; 218:14; 269:24; 270: 13; 273:7; ,283:12
14,16;269:12, 23;270:5, 14; 13:6, 12; 14:23; 15:4;
252:10, 12; 261:18; 275:3; 284:7 labies 46:20; 99:2;
14;271:2, 7;274:5; 276:8; 19:8,9, 11;21:11; 26:24;
277:2, 12;278:4; 280:2, 28:18, 25;30:4; 31:10, 13; 266:23; 267:2,4,5,11,12, SUppOrtSd 220:13; 190:22
18,18, 22;281:10,18, 19; 33:3, 22;269:11;270:13; 252:8; 268:5 kblet 13:23; 166:13;
12;34:8, 14;39:20,
282:14,16,17, 23;283:1, 24;40:4; 43:4,7,13, 23; 273:22; 279:10,12, 22; supporting 39: 16; 258:14
6,7,13,14,16,18, 19,21; f4:10, 13,16,22, 24; 280:16; 281:1; 283:2,4,9, 176:17; 271:1; 273:23 lactic 281:6
284:5,16, 23;285:2,4,5, 52:16; 54:15,17,19,21, 15 supportive 21:4; 70:1; rALARICO 4:22, 22;
11,13,18,19,21, 22,24; 23;55:3; 56:13; 58:3; substantiation 205:21, 150:2 k13; 10:9; 245:2; 254:24;
286:10,12, 14;287:4,5,8, 59:16,21,21, 24;63:7; 22 supports 80:21; 186:12; ,257:7,8; 267: 19; 277:5,6,
17,25;288:11, 15;289:23, 71:13,18, 21;72:9; 73:8, subtle 224:16 195:1 ;275:2 [7, 24; 288:24
24;290:18,19,22, 24; 14;77:14; 78:13 ;83:14; subtypes 90:20 suppose 88: 14; 107:6; Talarico’s 8:15
291:4; 292:12,17,24 34:8,8, 24;97:2,9; 98:19;
SUCCeedSd 126:13, 14 219:19; 265:1 Italk 52:22;75:2,3; 78:18;
stroke+ 20:12 99:3,8, 13;102:2; 104:20;
successful 73:9 SUppOSSd 252:5; 256:21; 178:1;
194:12;
229:10;
stroke-free 151 :23; 105:17; 106:6,14, 25;
SUCCeSSfU[iy 177:20 272:15 ,251:9
216:9,10 107:2,5,7, 13;112:18;
114:22; 115:16, 17;116:5, sudden 23: 1; 46:9, 12, suppresses 35:22 talked
84:23;203:23;
stroke-related 25: 16; 204:5;
207:11;
227:4;
16,23;120:3; 130:25; 13, 14; 76:21,23, 23; SUppreSSiOn 87:11
49:7 255:17
131:8; 135:5; 138:12; 140:16,18, 19; 141:19; sure 36:24; 39:25; 45:10;
stroke/death 292:25 146:12; 147:11, 14;148:8, lalking
20:10;23:25;
155:24; 168:10; 170:17; 64:5; 67:9, 17; 97:25;
strokelhll 61:9 15;149:6, 6;151:21, 2,2; 172:13 ;23~:ll 102:10; 127:24; 144:22; i9:22;
56:8;
131:3;162:2;
strokes 40:22; 45:15; 156:5; 160:16; 161:20; SUffer 197:14; 202:14, 148:2; 162:24; 171:9; 176:24;
177:4;
231:10;
46:11; 47:9,13, 24; 48:2; 162:12, 21;163:25; 164:2, 16; 236:19 182:13; 222:1, 22; 234:22, 249:5;
253:1;
261:25;
49:1; 50:2,8,23, 23; 70:9, 3;166:7; 167:11; 172:6,7, 23; 243:11; 256:23; 274:5;
275:6;
287:2,3,4
SUfferSd 202:3
11;72:8; 98:23, 24; 7,12;173:6; 175:1,7; 258: 14; 267: 13; 269:7; talks 207:9
103:18; 104:8; 132:23, 25; 177:4,7; 184:21; 185:15; suffice 26:6; 38:2; 136:20
270:23; 282:24 Rengentially 229:6
135:3,3,4; 136:13, 16; 190:8, 21;191:2; 204:1,8; sufficient 33:7; 37:23;
surface 81:3 Iarget 86:23; 209:6
138:7, 11;139:5,11,15, 205:15, 22;206:4,9,18, 38:8, 20; 43:19; 58:18;
154:20; 172:25; 271:5; surgery 16:24; 50:17 ‘Task 200:24
15;152:2,8; 153:21,22; 18,22;207:2,7,20, 25;
161:22; 162:10, 13,25; 208:7,8,11,14,16, 17; 272:12; 284:7; 286:22 surprising 173:16; TASS 59:21, 24; 62:7;
169:1; 173:24; 174:9,11, 209:3, 4;214:18; 218:14, suggest 29:13; 30:18; 185:24 63:7
12,18;194:24, 24;195:6, 16;219:18; 221:1,2,7; 37:15; 50:15; 161:16; surrounded 13:24 Iaste 73:21; 74:1, 13;
12,13, 14;241:4,4, 5; 224:6,10,11, 15;225:3, 4; 269:22 surrounding 47:12; 78:11:276:14.15
,-
M~er Reporting Company, Inc. Min-u-scriptml (27) stroke--in - taste
Advisory Committee Food and Drug Aclministration
Vol. 1, April 28, 1998 Peripheral & Central Nervous System

taught 115:20 thankless 9:8 thoughts 232:13; 245:10 245:15,17;259:10 tr 190:22


-teapot106:16 Thanks 7:22 thousand 21:13 ;31:5 TIAs 40:22;43:11,
17; track 138:11,12
~=h 115:24 that-and131:1o thousands 262:1 45:16;48:15;136:13,
14; tradition 272:18
‘nical 105:5;126:17; that-it
110:22 threat 49:22,25 138:2;162:12;248:25; traditional 236:24 ‘
. ./. 259:15
‘3 that-not280:25 three 9:8; 34:6; 53:23; transient 10:21; 11:20;
technically 8:3 Ticlid 6:16; 285:12
that-there234:8 54:12; 55:16; 60:11; 18:11 ;48:11;141:7;
61:19; 63:3; 64:7, 14; ticlopidine 45:25; 51:6; 198:6; 212:24; 254:16, 19;
telecon2274 that-you39:19
67:12; 90:24; 91:13; 53:12; 59:12,16,17,22, 257:10
telling 113:21; 149:7; the-1224:18 24;60:2, 15,18, 20; 61:20;
272:5 95:15; %:13, 20;97:4; translate 14: 13; 27: 19;
themselves4:5;7:13; 99:23;
105:5;106:6,
7; 62:7; 63:7,11, 24;65:25;
tempest 106:15 65:13 66:7,
12;116:23 152:3
115:6;
130:9;131:22;
Temple 17:25; 18:3,
3; theoretical 119:11 TID 14:5 translated 27:21
135:16;
1368;137:16, 20;
22:21, 22;25:9,19;36:7; theoretically 229:14 tie 266:9 translates 51:23
154:1;
177:8,10,20;
39:7, 23;68:5;72:23,
24; theory229:18; 242:11 179:21;
180:9;195:17; tied 292:3 translating 86:25
74:12; 75:1,11;76:3;
77:7, therapeutic 90:1;191:23 208:13;
227:19;228:19; ties199:16 transparencies 215:8
8,25;78:8; 109:20;112:7, 230:15;
232:20;242:18; transparency 217:9
therapies 195:23; time-and 121:21
8,24;117:24; 118:1,22; 250:21;
261:4,7;269:3,3,
201:20,25 times26:23; 50:3; travel 48:2
130:4,5, 14;146:8,9; 18;270:8,
21;271:25;
therapy 50:20; 60:11; 102:24;137:16,20;173:2; treacherous 23:2
147:12; 149:5;167:4,5; 273:9;
278:12,16,17;
66:2;193:9; 202:9; 208:13;215:18;226:17, treat 190:23,23
171:23, 24;172:19; 281:8,9,
16;285:1,3,6,
204:25; 205:8; 245:15 19,20;245:25;286:15
175:16, 17;215:10; 17;286:14 treated 21:14; 38: 19;
219:21, 25;221:24;222:1;there-but 288:13 tissue257:17
three-fourths 96:24 43:18; 81:24 ;152:4;
223:25; 224:1;228:5,6,7;there-well 285:3 Titus5:21,23;10:9; 156:16; 172:13; 192:19,
three-month %:13
236:11, 12;237:17; thereabouts 125:12 78:18 20, 22; 194:20; 196:23
three-page 176:7
241:24; 243:16,17;254:8,thereafter %:14 today13:16; 16:9;45:24; treating 72:7; 163: 12;
three-part 92:3
12;256:18; 260:15,16; thereby 85:3, 8; 86:13; 94:21;109:18;121:23,23; 166:18; “194:24;195:3;
264:15, 16;265:15; three-year 241:11 129:16,24;130:2;157:11; 200:20
202:14
267:10;269:4,7,13,16, thrombi 48:14; 81:3,13, 160:6;194:12,22;1%:20,
Therefore 7:8; 11:6;
22;272:23; 273:8,21; 15, 18;82:4,6, 14,17,19, 24;197:8;199:8;203:16, treatment 17:19, 21;
20:1; 24:19; 38:11; 69:23; 29:9; 43:11; 44:8; 49:17;
276:13;278:2; 279:24; 20, 25; 83:3,18,19,23, 24;204:6,20;251:17;
70:12; 71:1 1;77:9; 80:22; 50:25; 7:1:19;81:25 ;82:1,
280:11, 15;282:13,22; 25; 84:2; 86:16 253:2;
274:8
86:15, 23; 88:3; 93:7; 5,10,11 ;83:1,14,21,22;
283:7; 285:7,14;287:12, 108:16; 109:5, 14; 115:8; thrombocytopenic 60:7 today’s 30:3, 16; 121:24
95:24; 96:5,10,12, 23;
.#’i?$’2:9
~ple’s 103:11; 278:21
137:17; 145:13; 165:5;
167:10, 20; 191:18;
thromboembolic 204:25
thrombogenic 81:3
today-and 110:21 97:12; 99:4, 11; 102:2;
together 12:11, 19; 104:3; 105:23; 106:3, 19;
.d93:24; 160:2; 164:6; 201 :20; 205: 10; 229: 18; thrombosis 141:14; 51:18; 54:6; 61:16; 67:14; 107:19; :110:8;115:12;
;83:20; 251:13 ;258:16 231:24; 234:5; 250:13; 155:20 70:10; 145:10; 166:13; 124:5 ;125:3; 131:12,13;
tended 214:18 257:1; 263:11; 286:20 thrombosis 173:6 274:4 133:3; 150:25; 151:1,1,3,
tendency 35:24 thinking 33:19; 52:25; thrombotic 47:18; 60:7; told 8:3; 23:21; 100:9; 5,6,10, 19; 165:6; 169:21;
74:2; 116:22; 233:19; 114:7; 118:12; 126:21, 23; 171:1,6; 174:11; 181:22;
tends 182:8 80:16; 255:2,25
235:9; 254:23; 255:16; 227:14 ;27613 182:6, 6; 186:6,7; 194:20;
term 12:21 ;38:19;42:ll;266:25; 279:18 thromboxane 85:1,2,3, 196:25; 201:4, 21; 202:20;
5,13; 87:11 ;92:17 tolerability 95:17
49:23; 55:8 210:4, 11;212:8; 213:3;
third 18:1 5; 48:20; tolerated 60:20; 95:13
terms31:14 ;34:5,21; thrombus 79:19; 80:13; 214:4,6,7,10,12,22, 23;
173:10; 197:16; 204:3;
58:7; 60:19;64:8;67:19; 81:10,11 ;82:10; 84:21; Tom 173:6 225:19; 229:17; 237:3, 25;
216:24; 220:14; 235:10,
92:5; 106:17;113:12; 85:4, 22; 86:6,14, 15; tongue 38:23 246:25; 251:19; 282:16;
13; 252:15; 253:7
131:19; 138:1;152:22; 87:15 ;88:1 took 51:15 ;125:ll; 290:17
Thirdly 92:7
155:12; 184:9;212:13; throughout 88:23; 129:6,7; 131:20; 142:2; treatments 66:25;
214:3; 230:8;232:8; this-but 174:1 160:22; 214:5 149:24,24,25 107:14, 1[5,17, 21; 152:20;
242:22; 261:5;277:18; this-is 232:25 throw 161:1; 236:12 top21:lo; 155:12 198:18; 224:3
285:10 this-this 57:1o throwing 23:11 topic 117:16 trend 15:15; 37:2; 56:14,
terrible 161:19 Thomas 17:5; 79:7 18; 57:2; 67:14; 69:2, 18;
thrown 164:20; 242:18; total 21: 1; 23:4,9, 23;
terribly 264:6 thorny 126:17; 131:8 292:4 44:17; 49: 13; 70:9; 83:2; 31:4,15, 20; 156:12;
territory 229:8 thoroughly s:9 Thus 24:15; 87:12 118:11; 122:22; 132:24; 165:16; :[66:8; 167:1;
test 14:16; 22:3; 42:12; though 24:22; 39:10; 138:7; 180:19, 21; 184:19; 193:2
TIA 11:24;12:2; 14:18;
43:25; 44:4; 84:4; 94:25; 53:17; 56:2; 104:10; 22:10;34:7,
24;37:7,25; 185:1,2,4, 7; 186:3; trended 183:22
107:20; 125:2; 145:22, 22; 105:
14;130:9;
133:2; 41:19; 48:10,11, 204:12 ;235:12;255:20
45:20; trends 15:5; 58:7; 159:5;
161:1; 165:7; 190:5; 134:20;
158:19;
163:3; 16;50:11, 52:2, total.~ 37:22; 40:5;
14;51:5; 165:17; 239:21
215:14,19; 217:19 167:11;
171:10;
175:23; 5;54:16,20, 41:23, 24; 43:12, 19; 69:4;
3,9,18;53:2, trial 8:17;12:1, 23;14:16;
tested 40: 13; 59:20; 61:6; 226:23;
229:23;
239:22; 23;56:10;57:18;
58:19, 70:7; 71:5; 101:11; 15:24;1!):20;
24:5;25:5;
93:5; 114:25; 206:16; 241:8;
257:18
;26Ck21; 21;59:5,11,
22;61:6,7; 120:20;
127:21;
245:22 29:17;30:12,18;31:5,7;
208:11,16 266:25;
275:6;
278:15 62:1;
65:21;70:22;
71:19; totally
35:22;100:20,
23; 32:2;
33:17,23;34:7,10,
testing 105:17; 147:1 thought 97:18; 122:17; 80:2,
18;95:3;96:23;
97:4; 153:23;
240:17;
244:12 24;35:13;39:15;40:7;
=&=~S 141:23; 142:3; 174:16; 177:4; 217:9; 108:9;
138:3;139:22; touched 286:17 41:1,
24;46:21; 54:16,20;
5 228:12; 232:7, 8,9; 148:22;
155:15;157:14; 55:10,1’1;
56:4,9,13,16;
tough 236:2; 288:19,22
233:13; 240:18; 249:18; 160:11,
18;161:6;162:19, 57:16;5!):15;
60:24,24;
Iwras 4:8; 16:12 toward 225:12
260:16; 267:5; 269: 13; 20;163:25;
166:10; 61:8,10;62:1,4,7;63:19,
textbook 271:16 272:14; 273:9,14, 17; 182:15;
187:21;188:8; towards 174:11; 183:22; 21,23;67:20;68:18;
textbooks 89:21 274:8; 278:4, 6; 288:23; 189:16;
202:3;204:18; 250:13 69:11,23;73:4;74:15;
th 209:4 289:9; 290:23 210:24;
213:1,10,12,13; toxic 36:1 76:21;77:1,1;91:11,18;

taught - trial (28) Min-u-script@ Miller Reporting Company, Inc.


Food and Drug Administration Advisory Committee
peripheral & Central Nervous System VctL 1, April 28, 1998

93:22;
94:19, 25;95:6,20, truth 74:20 ulcerations 36:8 unless18:7;
130:19; Iusing
32:5;74:6;
83:7;
23;98:8;100:5;101:1, 8; try 19:6; 65:8; 77:18; Ulcers 183:21; 184:4, 12; 259:19;
264:8;
272:1; 1B9:9;
102:6;114:21;
103:3,
5,6;108:10,21, 21; 179:17; 183:14; 186:3; 185:23 282:2 146:9;
183:13;234:1;
~-~
109:9,14,16;110:23; 203:9; 244: 16; 261:2 ultimate 78:4; 202:15 unlikely
63:14;201:18 .242:20
;271:19
111:19;116:23,24,25; trying 33:14; 70:2; 77: 17; unmeeningful 44:14 Iusual
22:5;111:22;
ultimately 262:14
117:3;119:19;120:8, 11, 222:12; 231:15; 236:3; 167:1
1;206:10;229:20
UMASS 4:17 unprecedented 172:1
25;121:5,15,17, 22; 243:17; 263:3; 266:16; Iusually
90:4;105:18;
122:1,19;123:4,9,13, 15; unable 172:2; 290:1 unravel 131:15
282:11 147:5;
205:17;208:8;
124:3;125:7;126:12; unaccounted 289:18 unrelated 6:23
TSU 105:4 :238:3;
241:12
131:6;137:15;151:14; unadjusted 218:5 unreliable 206:24
TTP 60:7,21 Iutility
201:6
160:17,18;172:25; 173:1, unambiguous 132:22 unspoken 250:19
7,7;175:6,10;176:9; tumor 189:2 utilized
253:20
unanimity 135:17; 136:8 unstable 38:1, 7; 175:24
187:21,25;188:2; 192:10; tumors 163:5
206:10;
209:23,
207:15,17;
24;210:2,7,10,
turn 80:1; 88:2; 156:14;
187:8; 193:25; 196:8
unanimous 117:19
unanimously 135:15
unusual 48: 16; 73:6;
150:5 v
23;211:1,3;212:7; unbiasly 239:2 Up 20:21; 21:15; 22:2;
213:12,14;214:5; 222:7; turned 108:16 26:20; 34:19, 22; 40:14, valid65:15; 121:7;
unbinding 102:15;
226:12;229:12;231:11; turns 46:5; 91:6 110:20,24 22, 25; 49:9; 59:4; 64:20; 188:16287:23
232:25;233:8,10,11, 24; twenty 9:13 uncertainty 204:3; 65:16; 68:14; 69:8, 19; validity 162:10,11
239:5;
241:20; 242:20; twice 83:12; 87:4; 152:7; 242:23 ;261:6 70:3; 78:3, 19; 85:25; valuable202:12
243:10,13;246:17, 21; 204: 12; 236:18 101:19; 107:2; 117:1;
unclear 73:20; 260:18 value99:14; 112:5;
247:1,
5;249:22; 252:25; two 5:3; 12:9; 13:19; 123:5; 124:2; 127:22;
uncomfortable 259:4 130:8;215:22; 289:15
255:9,
9;256:13; 273:6; 14:10, 13; 18:14; 21:11; 128:25; 129:15; 132:4;
284:7,
21;289:7; 290:4 uncommon 23:8; 139:19; 150:11; 153:19; values27:21; 153:17;
28:7; 29:11 ;31:11; 38:9; :223:12; 225:1;237:13
trial-those35:11 185:17; 186:24; 292:3 160:25; 164:4; 165:8;
50:8, 21; 53:1 1; 57:24;
under 13:16; 32:19; 168:19; 170:24; 174:15, valve48:1;205:1
trialist
24:12, 22;25:1; 58:11; 59:10, 14;66:10;
26:17;
27:8; 53:21; 134:6; 87:13 ;88:9,11; 95:1,11; 38:23; 105:13; 106:8; 17; 184:13; 193:24; 208:2; ‘1/AN 4:6,6;9:5;110:2, 12;
137:18;140:17;274:21 96:1O, 11; 99:7; 112:25; 110:10;
112:4;
116:4; 214:1 ;221:16,24; 222:12; 112:3;132:7; 143:16, 18;
115:6; 120:22; 122:11; 121:24;
140:25;
195:15; 234:15, 19; 242:12, 23; “144:8,21;145:21; 194:5,
Trialists 51:13
123:1; 124:2,4; 128:17, 229:18 246:3; 247:20; 251 :7; 13,9;262:11, 12;270:3, 18;
trials 6:21; 12:4, 9; 22:3,
18,19, 20; 129:2, 9; underestimate 187:24 253:22; 262:19, 24; 272:6; :271:10; 278:17;291:1,3
5, 24; 23:8; 29: 13; 30:7,9; 274:9; 282:9; 286: 17;
31:25; 33:22; 34:6; 41:5; 132:23, 24; 143:10, 12; undergo 16:23 variability 44:6; 225:11
144:2, 3; 145:4,6,7,8, 23; 291:6 variable 101:22; 102:5
43:19; 52:9, 19; 56:9; undergone 55:9
.~_ 146:10,12, 22; 151:24; updates 104:3 variations 118:4
59:14; 62:16,20; 63:1,3, underline 29:3
10; 64:10, 14; 67:6,12, 24; 156:9; 157: 1; 159:20; upon 7:18; 18:19; 65:19; variety 22:14;51:16;
underpaid 9:8
68:2,2,3,4, 16;69:21; 168:15; 171:4; 179:24; 71:12, 23; 113:10; 159:20;
underpowered 12:5; 168:11; 194:16
88:11, 23; 89:9; 90:25; 180:2, 3; 183:6; 190:10; 165:14, 21; 166:22, 23;
192:19,21,22;202:4; 31:13; 67:25 various6:22; 33:23;
91:12; 92:22; 103:1; 190:6; 232:16; 244:25;
207:8;208:9;
215:11,20; understood 127:25; 84:5; 141:25; 160:5;
113:10; 130:16; 133:12; 246:5; 247:5; 253:8;
216:19;217:24;218:2,3; 220:18 1225:2;246:24; 278:9
145:9; 165:17; 167:2,6, 259:6; 278:12; 286:25;
220:10;221:15;222:8; 289:24 vary39:7
23; 170:12; 172:1, 21,24; underwent 210:9
173:6 ;175:17;207:14; 226:11;227:7,12;230:15; undetermined 185:20 upper 188:16 varying197:15
222:9; 231:8; 237:25; 232:19;236:24;237:2; vascular11:3; 28:12;
undoubtedly 111:3; upsizing 233:11
239:14; 240:2; 241:10; 241:11;243:10,13,19; 38:21 ;49:25; 50:5; 51:11,
260:25 uptake 27:14, 17; 86:3;
271:17 ;275:13 244:12,21,22;253:6,8; “16,18,20;55:8, 25;61:3;
258:12;262:13;266:12; unexpected 121: 18; i37:l, 12; 92:18
trials-and 62:18 63:9; 140:21; 141:10, 10,
267:19,20;272:23;277:8; 179:22, 23; 184:24; upward 117:3 15;155:19; 170:17;
trick 143:20 282:8;287:19 186:12 ;239:17 urge75:ll; 130:15; 182:16;239:14; 241:10
tricky 264:24 twodrug 224:2 unexplained 235:11 202:19 vasoconstriction 85:6
tried 22:24; 75:5; 84:5, two-times-two 12:16 unfortunate 119:18 urging77:9 vast38:18;191:24
10; 156:15; 187:18; 241:9; unfortunately 9:2; USC 6:9; 7:2
two-year 142: 15; 152:4 vehemently-1271:13
244:17; 258:13 16:20; 50:21 ;63:14;
type 27:25; 28:1; 60:14; use 11:8; 25:24; 28:10, vein141:14; 155:20
trigger 100:4,7 248:16 1030:1,13;56:24; 59:11;
96:8; 105:17; 110:1 1; versus34:8, 11,12;40:4;
triggers 80: 17; 85:6; 132:10;
157:13;
182:22 uniform 208:15 73:16; 77:9, 25;145:23;
86:8; 92:16 148:9; 154:9, 15;169:22; !52:10,25; 53:6;54:18, 19,
types51:12;
141:21; uniformly 67:6; 113:10;
:21;55:5; 56:4,10, 13;
triple 276:24; 289:5 207:4;
246:24 114:18; 172:2 179:14; 183:23; 184:1;
186:13; 213:18; 232:3; ‘57:12,18;59:16, 22;
trouble 39:2; 75:9; 80:2; typical 73:4 union 230:16; 231:9; 61:24; 62:9;66:7; 67:11,
130:21; 161:19; 173:19; 232:1 6; 233:1,2 252:21 ;255:4; 261:11;
typically 4-:5,75, 20;68:23; 91:14; 119:12,
263:9, 21; 286:3,13 265:2; 279:15
48:15; 257:19 unions 231:16 13,14, 23;126:6, 7,9;
true 25:10, 11; 30:5, 6; USed 12:16; 38:12;78:2; 149:8,9,14,14,24, 25;
UniqUe 81:17
81:21 ;83:14; 88:25;
32:23; 57:6; 71:22; 76:3;
77:8; 102:5; 108:19;
109:12; 115:10, 11;116:6,
u llnit 16:17; 199:2,8
L!nited 28:23; 48:21;
90:14;
102:1,6;
97:23; 1o1:22,
107:11, 12;
23;
150:1;151:25;
153:1,1,6,
152:13;
11,12;158:11,
12,15;159;4, 5;189:14;
–~. 15;118:2,3,9;125:18; 49:1, 14; 195:5, 8; 199:20; 118:12; 154:19; 175:17,
U.K 16:14 218:17; 219:19; 275:22
190:18; 192:20, 21;208:2,
164:1;165:13,22;171:9, 19,20;176:2; 224:13,13;
U.S 19:12; 173:7; 204:23; :3,4,13, 17;213:13,15,
11,14;176:21;181:2; unity 69:17; 91:5 227:25; 228:1,3;263:6; 20;215:12, 12,13,21,22;
210:18;224:1;231:16; 209:5 University 4:6,8,13,16, 271:14; 273:25; 274:1 216:2,3,5,6, 13,17,20,
237:24;240:1,7;283:4; U88-0473 208:16 19;6:19; 10:3; 16:11,12, useful132:1; 268:6; 23;217:10,13, 17,21;
285:14;290:9 UK 34:10, 24; 54:16,23 17, 21;94:15; 199:3,6 280:3 218:19,22, 25;219:2,4;
truly 144:18; 180:3 ulcer 97:8;185:12 unknown 140:20,25 uses 277:3 224:3; 231:22; 237:10,15,

Miller Reporting Company, Inc. Min-U-Scrip@ (29) trial--those - versus


Advisory Committee Food and Drug Administration
VOL 1, Aprfl 28, 1998 Peripheral & Central Nervous System

16; 246:21 warning 201:6 230:10,10,


12;234:10 12;168:25
- vessel 47:9; 79:20; 80:4, warp 76:18 wind 40:22, 25; 132:4; worry23:4;
105:18;
221:1
=x 16; 92:16 warrant 286:22 222:12; 234:19; 282:9
worse 286:20
“~els47:10, 17, 18; warranting 203:15 winding 174:15,17
..,.4, 5; 257:17 worst107:14,
17;132:2;
Washington 4:7 winning 228:11
vestige 290:15 161:1
water 164:20; 165:11 wins 77:12; 147:9
Viagra 90:16 wisdom 42:7
worst-case153:22
way 5:5; 21:24; 25:22;
Vice 10:5, 14; 194:5,10 32:12; 33:11,12; 39:10; wisest 41:13 worth33:18;
45:11;
view 8:16; 19:19; 25:25; 44:22; 45:10; 644, 12; wish 7:18; 21:15; 193:21; 138:24;
229:7,
8;235:9;
26:5; 30:4,4, 16; 33:3; 69:25; 75:15,19, 22; 253:21 ;267:15 239:21
37:22; 42:23; 43:13; 65:8; 102:24; 105:15; 115:24, wishes 203:1 worthwhile 132:6; 284:5
77:22; 79:9; 93:16; 25; 116:5; 11721; 118:10,
withdraw 267:21 worthy 281 :17; 288:23
106:11;111:8;
113:18; 24; 134:16; 139:14; 1492;
150:18;152:9;
160:21; 151:2; 163:11; 164:24;within 7:1; 14:11 ;24:21, wrap 78:19
164:24;173:17;
174:14; 182:13; 194:19; 1%:23;24, 25;31:12, 20;33:22;
wrestle 76:8; 77:6
237:21;239:19;
243:9; 42:5; 47:11 ;77:11; 96:20;
222:1,5, 11;228:14, 16;
97:4; 134:14,17, 22;
230:10,24, 25; 232:6,11, wrestling 115:19
278:12;292:13
21;235:4;
236:9;
237:9; 140:20; 142:9; 146:15; written 6:12; 24:23;
viewed 71:20; 124: 18;
128:7; 129:16; 194:19; 239:9, 261:16; 170:14; 186:6; 188:10;
13;251:16; 68:13; 75:23; 121:23;
264:1; 269:19;270:10, 22; 207:8;
222:6;
244:7
196:23; 207:8; 238:15 164:9; 167:8; 195:13;
271:17,18, 25;273:24; without15:1;
41:25;
43:6;
viewing 242:22 221:16; 253:22
276:18; 282:1;289:20; 57:15;
66:8;
68:10;
77:2;
viewpoint 281:8 290:10 ;291:16,21,25; 107:19; 110:17;
114:9; wrong 45:17 ;75:15, 19;
VigOrOUS 292:18 292:2 118:10;
123:16,
16; 109:11;
149:5;
246:22;
violate 121:1 way-reported 172:8 139:11;
140:22;
229:15; 269:19,
19;270:20;
violations 248:15 ways 72:10; 222:6, 10; 253:3;
261:16;
271:2; 290:22
;291:19
230:9,12 288:4
virtually 83:21; 152:18; wrote37:20;
134:15;
211:25 weak 175:21; 217:11, 19; withstanding 7:4
136:13;
243:17
vis-a-vis 90:17; 138:22 218:11 women 26:25; 40:5;
weaker 218:7, 11 43:11,13,14,15,18,20,
Visiting 16:13
visits 24:4; 96:12 Wecksler 27:6
20; 97:2
Wornen’s 26:24; 39:20;
x
_#=+l 202:1 week41:ll
94:8
/ 192:1 weeks 161:24 K95:23; 149:3
won 78:10
volunteers 38:7 weighed 248:21
wonder 78:9; 161:14, 17,
vomiting 183:18; 214:14 weighs 236:25 19, 25; 236:21
vote 266:5,9, 10; 267:24, weight 182:22 wondering 169:13
Y
24, 25; 269:14, 24; 271:4, weighted 241:15 word 89: 18; 150: 15;
13; 272:14,18, 20; 273:14; welcome 4:3; 7:24; 8:14, 160:8; 206:7; 270:20; year 11:4,16;49:2,
14;
276:22; 277:18,21, 25; 20, 25; 9:3, 22; 94:16 271:15,15 98:13,18;102:21;108:5;
278:9; 280:22; 281:4,12, well-controlled 160: 14; worded 125:6 113:13;125:12,16;
14,15,19, 23; 282:3,5,8, 205:18
14; 283:4, 20; 290:24; wording 124:24; 168:22; 131:21;137:17,20;183:6;
welldescribed 29o:2 257:4; 263:25 195:5;197:13;201:12,14
291:3
weren’t 77:20; 108:23; words 20:12;64:2; 104:7;
voted 269:17, 19; 270:8, yearly97:19;98:8;
101:9;
151:11 ;168:25 114:7;128:5;
129:19;
21; 273:8,10, 24; 276:18; 103:9
281:3,7, 19; 282:19,22 what’s 144:24 136:8;138:3;
139:15;
what-1 242:14 148:7;163:7;
164:20; years9:7,8,13,19;
voted-is 283:3
254:13;256:9;
270:4; 21:11;
49:24;
50:4;75:4;
votes 271 :25; 278:12, 16 whenever 85: 18; 90:6
273:17 77:4;
%10, 11;106:7;
votes-but 266:21 whereas 38: 14; 83:23;
work 27:5; 32:3; 84:13; 113:14;
122:11;124:2;
100:19; 209:9
voting 267: 14; 278:9; 115:22, 25; 132:8; 143:11;
Whereupon 178:4 127:21;
130:11;149:16;
281:10 ;290:22 149:1; 155:5; 159:25;
whites 32:12 187:23; 264:3; 274:4; 151:24;
175:4,
6;183:7;
VS 218:9
whole 26:8; 73: 17; 77: 10; 281:6; 292:21 192:19,21,
22;199:22;

w 81:2; 92:2; 112:18;


126:25; 181:3; 183:17;
worked 117:10; 148:11
working 26:22; iOk20,
215:20;
216:19;
yellow21:10
271:17

208:20; 235:13; 236:23; 25; 115:25; 200:18;


237:9; 287: 16; 288:3,9 yield 12:7,18
wait 122:25,
25;194:3; 265:23
234:13 whose 7:17; 196:21 yOU-iS 23:3
works 36:17; 86:14;
waiver 6:11 wide 26:19; 51:16; 67:13; 147:20, 21; 148:9, 23; younger 221:5
waivers 6:10 68:18; 69:21 ;241:1 163:12; 254:22; 265:22; your-so 34:20
_=- widely 11:13 279:21; 280:22
16:17
‘>S yourselves 17:25
.,1
79:21;
80:7,8,24; Wllcoxon 218:5,10 world 12:24; 13:1; 70:7,
9, 12;71:19; 245:15
92:16
wants 239:3;
254:14;
will-we 5:13
willing 162:5; 259:19; world’s 245:14 z
265:2 284:20 worldwide 48:20
wards 48:21 win 147:6, 8;208:24, 25; worried 77:19; 132:10, zero 57:7; 83:21:185:25

vessel - zero (30) Min-U-Script@ Miller Reporting Company, Inc.