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Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure: enrollment and data collection
| Baseline t-1 | Randomization t0 | 6-month follow-up t1 | 12-month follow-up, t2 | 24-month follow-up t3 | |
|---|---|---|---|---|---|
| Informed consent | X | ||||
| Case Report Form (CRF) from personal interviews | X | ||||
| Randomization database | X | ||||
| Registration sheets | X | X | Continuous registration | ||
| Self-assessment data | X | X | X | X | |
| Register data | X | X | X | X | |
