Table 2.
The study plan. Patients who did not complete V5 had an antibody level assay performed from V4. Some patients had combined V4 and V5 visits due to the population vaccinations against COVID-19 introduced and the need to accelerate visits.
| Stage of the Study | Stage 1 | Stage 2 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Visit/Contact | Visit 1 (V1) | Visit 2 (V2) | Visit 3 (V3) | Weekly Phone Call | Visit 4 (V4) | Weekly Phone Call | Visit 5 (V5) | Visit 6 (V6) | Visit 7 (V7) |
| Signing the informed consent | X | X | |||||||
| Taking medical history | X | X | X | ||||||
| Setting up tuberculin test (RT23) | X | ||||||||
| Blood sampling | 2 × 5 mL | 5 mL | 2 × 5 mL | 2 × 5 mL | 2 × 5 mL | ||||
| Assessment of the tuberculin test | X | ||||||||
| Randomisation | X | ||||||||
| Telephone call | X | X | |||||||
| Unblinding of the study | X | ||||||||