Table 1 Assessment timetable for the treatment group
Telephone screening | Screening | Baseline (Wk 0) | Intervention | Follow-up | ||||
|---|---|---|---|---|---|---|---|---|
Wk 1–Wk 3 | Wk 4 | Wk 6 | ||||||
Visit number | 0 | 1 | 2 | 3 (tel) | 4 (tel) | 5 | 6 (tel) | 7 |
Day | − 28 to − 14 | − 13 to − 7 | 0 | 7 ± 2 | 14 ± 2 | 21 ± 2 | 28 ± 2 | 42 ± 3 |
Screening information | ✓ | ✓ | ||||||
Informed consent | ✓ | |||||||
Review In/Ex criteria | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Medical history | ✓ | ✓ | ||||||
Demographics | ✓ | |||||||
Blood test | ✓ | ✓ | ||||||
Primary outcome | ||||||||
FDDQL | ✓ | ✓ | ✓ | |||||
Secondary outcomes | ||||||||
HADS | ✓ | ✓ | ✓ | |||||
EQ-5D-5L | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Concomitant medications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Safety and tolerability | ✓ | ✓ | ✓ | |||||