Table 3B. Schedule of events; treatment period.
Treatment Period | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Month 1 - weeekly visits | Month 2 - fornightly visits | Month 3 - fornightly 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 |