Visit 8 to visit 10 (year 1 to year 3 ± 21 days) of follow-up phase
The follow-up visits will take place annually until year 3, i.e. visit 8 (1 year after randomisation), visit 9 (2 years after randomisation) and visit 10 (3 years after randomisation).The panel of assessments for the follow-up visits is shown in Fig. 