Visit | 1 (=Screening) | 2 (Operation) | 3 (day of discharge) | 4 (30 days post OP) | 5 (12 ± 1 months post OP) |
---|---|---|---|---|---|
Demographics and baseline clinical data | X | ||||
Eligibility criteria | X | ||||
Randomization, Surgical intervention | X | ||||
Clinical visit/Follow-up | X | X | X | ||
Quality of life (EuroQol 5 D) | X | X | X | ||
Safety | X | X | X | X |