Date

2025-08-11

Protocol

Protocol changed

Item Changed

Secondary outcome(s) - Time of assessment(s)

Previous Version

1. 1-6 = From randomization until the common study end date (median 2 years) 2. 7- 12 months 3. 8-14 = From randomization until the common study end date (median 2 years)

Next Version

61 months