Baseline period | Within 28 days before randomization |
---|---|
Visit 1 | Day 0 (up to 7 days after randomization) |
Visit 2 | Day 7 (±2 days) |
Telephone visits 1 to 9 | Weeks 4, 8, 16, 20, 28, 32, 40, 44 and 48 (±7 days) |
Visits 3 to 5 | Weeks 12, 24 and 36 (±7 days) |
Visit 6 | Week 52 (±7 days) or shortly after close-out |