| Study period | |||||
---|---|---|---|---|---|---|
 | Enrollment | Allocation | Postallocation | |||
Time pointa | Day 0 | Day 0 | Day 0 | Day 3 | Day 7 | Day 42 |
Enrollment | ||||||
 Eligibility screen | X |  |  |  |  |  |
 Informed consent | X |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |
Interventions | ||||||
 Procedure by CO |  |  | X |  |  |  |
 Procedure by AMO |  |  | X |  |  |  |
Assessments | ||||||
 Pregnancy test | X |  |  |  |  |  |
 Directed physical examination | X |  |  | X | X | X |
 Adverse events |  |  | X | X | X | X |
 Interview |  |  |  |  | X | X |