Table 3.
Number of Study Arms (with One Placebo Arm) | Accrual Per Week During 52 Week Accrual period1 | Number Accrued Per Study Arm2 | Total Accrued (N) | |
---|---|---|---|---|
Initial 13 Weeks | Subsequent 39 Weeks | |||
2 | 47 | 95 | 2150 | 4300 |
3 | 71 | 142 | 2150 | 6450 |
4 | 95 | 189 | 2150 | 8600 |
These accrual rates lead to full accrual at 12 months since the first subject is enrolled, such that the maximum trial duration is 48 months.
Equal allocation of subjects to the study arms.