| Study period | ||||
---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | ||
Timepoint | -t1 | 0 | T0 | T1 | T2 |
Enrolment: | |||||
Eligibility screen | X | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â |
Allocation | Â | X | Â | Â | Â |
Interventions: | |||||
Intervention group | Â | Â | X | X | Â |
Control group | Â | Â | X | X | Â |
Assessments: | |||||
Primary outcome and secondary outcomesa | X | Â | Â | Â | Â |
Primary outcome and secondary outcomesa | Â | Â | Â | X | X |