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. 2024 Oct 21;9:488. Originally published 2024 Aug 19. [Version 2] doi: 10.12688/wellcomeopenres.22719.2

Table 3B. Schedule of events; treatment period.

Treatment Period
Month 1 - weekly visits Month 2 - fortnightly visits Month 3 - fortnightly visits
Week 1 Mon/Thu Week 2 Mon/Thu Week 3 Mon/Thu Week 4 Mon/Thu Week 1 Mon/Thu Week 2 Mon/Thu Week 3 Mon/Thu Week 4 Mon/Thu Week 1 Mon/Thu Week 2 Mon/Thu Week 3 Mon/Thu Week 4 Mon/Thu
Time window (+/- days) 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
Verbal consent X X X X X X X X
Examination X X X X X X X X
Vital signs X X X X X X X X
AE screening X X X X X X X X
Urinary bHCG (as appropriate) X
12-lead ECG X X
Laboratory safety assessments X X X X X X X X
Diagnostic sampling X
Treatment initiation X
Vitual volunteer diary X X X X X X X X X X X X X X X X X X X X X X X X
Self-collected photograph X X X X X X X X X X X X X X X X X X X X X X X X
PBMC collection X X X X X X X X
Serum collection X X X X X X X X
Microbiology blood sampling X X X X X X X X
Faecal microbiome sampling X X X X
Skin swabs X X X X X X
DLQI and GAD-7 questionnaires X X X X X X
Time (min) 120 10 60 10 240 10 60 10 15 10 60 10 15 10 60 10 15 10 60 10 15 10 60 10