Procedures | Recruitment VA/B | Baseline V1 (week 0) | Phone call (week 2) | Phone call (week 6) | Follow-up V2 (week 12) | Phone call (week 14) |
---|---|---|---|---|---|---|
Informed consent | X | Â | Â | Â | Â | Â |
Recent labs | X | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â |
Eligibility assessment | X | Â | Â | Â | Â | Â |
Demographics | Â | X | Â | Â | Â | Â |
Family functioning questionnaires | Â | X | Â | Â | Â | Â |
Concomitant medications | Â | X | Â | Â | X | Â |
Questionnaires | Â | X | Â | Â | X | Â |
Cognitive testing | Â | X | Â | Â | X | Â |
MRI if consenting and feasible | Â | (X) | Â | Â | (X) | Â |
Home oximetry if consenting and feasible | Â | (X) | Â | Â | (X) | Â |
Randomisation | Â | X | Â | Â | Â | Â |
Dispensing of trial drugs | Â | X | Â | Â | Â | Â |
Drug accountability | Â | Â | Â | Â | X | Â |
Adverse event assessments | Â | Â | X | X | X | X |