Table 3 Participant Timeline
Visits | Pre-Baseline | Baseline Day 0 | Randomisation Day 0 | Intervention Day 0 | 2-week follow-up | 2-month follow-up | 4 month follow-up | 6-month follow-up |
|---|---|---|---|---|---|---|---|---|
Duration of Intervention | ||||||||
Events | ||||||||
 Brief telephone screening (identified via route 3) | ✓ | |||||||
 Consent to eligibility screening assessment (route 3) | ✓ | |||||||
 Eligibility Screening | ✓ | |||||||
 Full informed consent by researcher/ research assistant | ✓ | |||||||
 Randomisation | ✓ | |||||||
 Participant Questionnaire (see Table 1) | ✓ | ✓ | ✓ | ✓ | ✓ | |||
 Web-based randomisation | ✓ | |||||||
 Administration of study intervention | ✓ | |||||||
 SAE reporting | ✓ | ✓ | ✓ | ✓ | ✓ | |||
 Expedited reporting (< 24 h) of Suspected Unexpected Serious Adverse Reactions (SUSARs) | On going | |||||||