Table 4 Participant timeline
Visit | Enrolment | T0 | T1 | T2 |
|---|---|---|---|---|
Time Point | Within 2 weeks before T0 | T0 | 6 weeks after T0 | 12 weeks after T0 |
Informed consent | X | |||
Physical/neurological examination | X | X | X | X |
Vital signs | X | X | X | X |
Unified Parkinson’s disease rating scale (UPDRS) | X | X | X | |
Hoehn and Yahr assessment (H&Y) | X | X | X | |
Zung self-rating anxiety scale | X | X | X | |
Beck depression inventory scale (BDI-II) | X | X | X | |
Composite autonomic symptoms scale-31 (COMPASS 31) | X | X | X | |
Montreal cognitive assessment (MOCA) | X | X | ||
PAC-QOL | X | X | X | |
Non-motor symptoms scale (NMSS) | X | X | X | |
Wexner scale | X | X | X | |
Constipation assessment scale (CAS) | X | X | X | |
Bristol stool form chart | X | X | ||
Blood withdrawal | X | X | ||
Treatment/placebo delivery | X |