Table 1. Schedule of visits during the study.
| Screening | Baseline/Treatment/Safety | Follow-up | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Before day 0 | 0h | 3h | 24h | 6h– 45h | 14–21
days |
5–6
weeks |
3
months |
||
| Informed consent | X |
Randomization
and treatment |
|||||||
|
Diagnosis (stool
examination) |
X | X | X | X | |||||
| Medical history | X | ||||||||
| Clinical examination | X | ||||||||
| Pregnancy testing | X | X | |||||||
|
Hemoglobin
measurement |
X | ||||||||
| PK (microsampling) | X | X | |||||||
| Capturing AEs | X | X | X | X | X | ||||
| Capturing SAE | X | X | X | X | X | ||||
Abbreviations: PK, pharmacokinetics; AE, adverse events; SAE, serious adverse events