Visit | Visit 1 (Screening) | Visit 2 (Day of surgery) | Visit 3 (Day of discharge) | Visit 4 (6 months post OP) | Visit 5 (12 months post OP) | Visit 6 (24 months post OP) |
---|---|---|---|---|---|---|
Demographics and baseline clinical data | X | |||||
Inclusion/exclusion | X | |||||
Randomisation | X | |||||
Surgical intervention | X | |||||
Assessment of secondary outcome measures and safety | X | X | X | X | X | |
Quality of Life | X | X | X | X | ||
Tissue and blood sampling | X |