Table
AD7 Study 212 Mean
(X) CGI-I (Values less than four represent improvement relative to time of
screening) |
||||||||||||||||||||
LAST OBSERVATION CARRIED
FORWARD ANALYSIS |
||||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|||
BUP SR 150 (L) |
146 |
4.0 |
145 |
3.4 |
146 |
3.1 |
146 |
2.8 |
146 |
2.7 |
146 |
2.6 |
46 |
2.5 |
146 |
2.4 |
146 |
2.4 |
||
BUP SR 300 (II) |
144 |
3.9 |
144 |
3.7 |
144 |
3.4 |
144 |
3.0 |
144 |
2.7 |
144 |
2.7 |
144 |
2.7 |
144 |
2.6 |
144 |
2.5 |
||
Placebo (P) |
148 |
3.9 |
145 |
3.5 |
148 |
3.2 |
148 |
2.9 |
148 |
2.9 |
148 |
2.8 |
148 |
2.7 |
148 |
2.7 |
148 |
2.7 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
0.03 |
0.36 |
0.35 |
0.49 |
0.20 |
0.15 |
0.05 |
0.04 |
0.02 |
|||||||||||
II vs P |
> 0.6 |
0.02 |
0.02 |
0.29 |
0.21 |
0.70 |
0.67 |
0.39 |
0.26 |
|||||||||||
OBSERVED CASES ANALYSIS |
||||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|||
BUP SR 150 (L) |
146 |
4.0 |
145 |
3.4 |
136 |
3.1 |
133 |
2.8 |
133 |
2.6 |
122 |
2.5 |
118 |
2.3 |
117 |
2.3 |
110 |
2.2 |
||
BUP SR 300 (II) |
144 |
3.9 |
144 |
3.7 |
136 |
3.4 |
131 |
2.9 |
121 |
2.6 |
111 |
2.5 |
104 |
2.4 |
104 |
2.2 |
101 |
2.2 |
||
Placebo (P) |
148 |
3.9 |
145 |
3.5 |
140 |
3.2 |
132 |
2.9 |
124 |
2.8 |
117 |
2.7 |
114 |
2.5 |
107 |
2.5 |
100 |
2.4 |
||
2-sided p-values for
pairwise comparisons |
||||||||||||||||||||
L vs P |
0.03 |
0.36 |
0.20 |
0.59 |
0.27 |
0.27 |
0.16 |
0.24 |
0.06 |
|||||||||||
II vs P |
> 0.6 |
0.02 |
0.06 |
0.74 |
0.03 |
0.28 |
0.35 |
0.13 |
0.06 |
|||||||||||
Bupropion SR Clinical Review Addendum for Protocol
212 21
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