Table 2 Assessment timetable for the waitlist group
Telephone screening | Screening | Baseline (Wk0) | Waiting period | Intervention | Follow-up | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Wk1 | Wk2 | Wk3 | Wk4–Wk6 | Wk 7 | Wk 9 | ||||||
Visit number | 0 | 1 | 2 | 3 (tel) | 4 (tel) | 5 | 6 (tel) | 7 (tel) | 8 | 9 (tel) | 10 |
Day | − 28 to − 15 | − 13 to − 7 | 0 | 7 ± 2 | 14 ± 2 | 21 ± 2 | 28 ± 2 | 35 ± 2 | 42 ± 2 | 49 ± 2 | 63 ± 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 | ✓ | ✓ | ✓ | ||||||||