| Baseline t-1 | Randomization t0 | 6-month follow-up t1 | 12-month follow-up, t2 | 24-month follow-up t3 |
---|---|---|---|---|---|
Informed consent | X | Â | Â | Â | Â |
Case Report Form (CRF) from personal interviews | X | Â | Â | Â | Â |
Randomization database | Â | X | Â | Â | Â |
Registration sheets | X | X | Continuous registration | ||
Self-assessment data | X | Â | X | X | X |
Register data | Â | X | X | X | X |