Visit | 1 (Screening) | 2 (Operation) | 3 (Day of discharge) | 4 (30 days post operation) | 5 (12 ± 1 months post operation) |
---|---|---|---|---|---|
Demographicsa and baseline clinical datab | X | X | |||
Eligibility criteria | X | X | |||
Randomization, surgical intervention | X | ||||
Clinical visit/telephone interviewc | X | X | X | ||
Quality of lifed | X | X | |||
Safetye | X | X | X | X |