Cohort A: three capsules once daily (84 mg) | | | | | | |
Continuous TIP | 14 | 2 (14.3) | 0 | 0 | 0 | 3 (21.4) |
Cyclical TIP | 13 | 0 | 0 | 0 | 0 | 1 (7.7) |
Placebo | 7 | 0 | 0 | 0 | 0 | 1 (14.3) |
Cohort B: five capsules once daily (140 mg) | | | | | | |
Continuous TIP | 15 | 1 (6.7) | 1 (6.7) | 0 | 0 | 3 (20) |
Cyclical TIP | 14 | 0 | 1 (7.1) | 1 (7.1) | 1 (7.1) | 3 (21.4) |
Placebo | 7 | 0 | 0 | 0 | 0 | 0 |
Cohort C: four capsules twice daily (224 mg) | | | | | | |
Continuous TIP | 15 | 0 | 2 (13.3) | 2 (13.3) | 2 (13.3) | 6 (40) |
Cyclical TIP | 15 | 2 (13.3) | 0 | 0 | 0 | 7 (46.7) |
Placebo | 7 | 0 | 0 | 0 | 0 | 1 (14.3) |
Total (n=107) | 107 | 5 (4.7) | 4 (3.7) | 3 (2.8) | 3 (2.8) | 25 (23.4) |