Table III.
FAS |
PP |
|||
---|---|---|---|---|
Response to treatment | BNO 1016 480 mg (n = 294) | Placebo (n = 295) | BNO 1016 480 mg (n = 213) | Placebo (n = 220) |
Visit 2 (day 3) | 57.8% | 55.6% | 60.6% | 55.9% |
p value*† = 0.5455 | p value*† = 0.3243 | |||
Visit 3 (day 7) | 86.1% | 78.0% | 89.7% | 76.4 |
p value*† = 0.0076 | p value*† = 0.0002 | |||
Visit 4 (day 10) | 90.8% | 80.7% | 95.8% | 80.5% |
p value*† = 0.0002 | p value*† < 0.0001 | |||
Visit 5 (day 14) | 93.2% | 85.1% | 94.8% | 83.6% |
p value*† = 0.0016 | p value*† = 0.0002 |
*Two-sided; alpha = 0.05.
†Cochran–Mantel–Haenszel test.
FAS, full analysis set; PP, per-protocol population.