| STUDY PERIOD | |||||
---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||
 |  |  | t 1 | t 2 | t 3 | t x |
TIMEPOINTc | 0 | 0 | ||||
ENROLMENT | ||||||
Eligibility screen | X | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â | Â |
Allocation | Â | X | Â | Â | Â | Â |
INTERVENTIONSa | ||||||
NSE | Â | Â | X | X | X | Â |
NSEIT | Â | Â | X | X | X | Â |
ASSESSMENTSb | ||||||
Demographic data | X | Â | X | Â | Â | Â |
Self-reported outcomes (questionnaires) | Â | Â | X | X | X | X |
Clinical outcome | Â | Â | X | X | X | X |