Study phase | Screening/consent | Baseline/randomisation | Treatment period (PTA) | Post-PTA | Discharge | Three-month follow-up |
---|---|---|---|---|---|---|
ACD/ MTDM identification | X | Â | Â | Â | Â | Â |
Trial introduction | X | Â | Â | Â | Â | Â |
MTDM consent | X | Â | Â | Â | Â | Â |
Screening | X | Â | Â | Â | Â | Â |
Participant consent | Â | Â | Â | X | Â | Â |
Randomisation | Â | X | Â | Â | Â | Â |
Demographicsa | Â | X | Â | X | Â | Â |
Medical recordb | Â | X | X | Â | X | Â |
Medical informationc | Â | X | X | X | Â | Â |
Blood test(s)d | Â | X | X | X | Â | Â |
WPTAS | Â | X | X | Â | Â | Â |
ABS | Â | X | X | X | X | Â |
Simpson-Angus Scale | Â | X | X | Â | Â | Â |
Administer treatment | Â | Â | X | Â | Â | Â |
Treatment log | Â | Â | X | Â | Â | Â |
AE monitoringe | Â | Â | X | Â | Â | Â |
RAVLT | Â | Â | Â | X | Â | Â |
SDMT | Â | Â | Â | X | Â | Â |
SF-12 | Â | Â | Â | X | X | X |
FIM | Â | Â | Â | X | X | Â |
MPAI-4 | Â | Â | Â | Â | Â | X |
PDHSUQ | Â | Â | Â | Â | Â | X |