|
Time
|
Sample
|
N
|
Mean (SD)
|
t-value (p-value)†
|
Effect size (Cohen’s d)b
|
|---|
|
Baseline
|
Post-baselinea
|
Change (SD)
|
|---|
|
Month 3
|
Total Sample
|
728
|
63.2 (7.5)
|
57.0 (9.7)
|
−6.2 (9.8)
|
17.12 (< 0.0001)
|
−0.83
|
|
Placebo
|
314
|
62.4 (7.4)
|
58.2 (9.7)
|
−4.2 (9.3)
|
8.02 (<.0001)
|
−0.57
|
|
150 mg
|
216
|
64.0 (7.8)
|
57.4 (9.5)
|
−6.7 (10.0)
|
9.79 (<.0001)
|
−0.85
|
|
200 mg
|
198
|
63.6 (7.3)
|
54.6 (9.5)
|
−9.0 (9.9)
|
12.90 (<.0001)
|
−1.25
|
|
Month 6
|
Total Sample
|
577
|
63.1 (7.5)
|
56.3 (10.1)
|
−6.8 (10.4)
|
15.76 (< 0.0001)
|
−0.91
|
|
Placebo
|
246
|
62.5 (7.7)
|
58.3 (10.0)
|
−4.2 (9.8)
|
6.73 (<.0001)
|
−0.55
|
|
150 mg
|
170
|
63.6 (7.7)
|
56.6 (9.4)
|
−7.0 (9.9)
|
9.24 (<.0001)
|
−0.91
|
|
200 mg
|
161
|
63.5 (7.2)
|
52.9 (10.0)
|
−10.6 (10.7)
|
12.64 (<.0001)
|
−1.48
|
- PROMIS Indicates Patient-Reported Outcome Measurement Information System, SD Half standard deviation, SEM Standard error of the mean
- †Paired t-test
- aMonth 3 or month 6
- bCalculated as mean change / SD for baseline score
