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

Table 3A. Schedule of events; screening and challenge periods.

Screening period Challenge period Month 1 Monthly until lesion reported
Mon Tues Wed Thur Fri Sat Sun 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
Study visit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Study day -1
to
-28
0 1 2 3 4 5 6 7 10 14 17 21 24 28 31
Time window (+/- days) 0 0 0 0 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
Eligibility check X
Written consent X
Verbal consent X X X
History X
Examination X X X
Vital signs X X X X
Screening investigations X
12-lead ECG X X
Urinary bHCG (as
appropriate)
X X X
Laboratory safety
assessment
X X X X X X
Excipient-only challenge X
M. ulcerans JKD8049
challenge
X
AE screening X X X X X
Virtual volunteer diary 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
PBMC collection X X X X X X
Serum collection X X X X X X
Microbiology blood sampling X X X X X
Skin swabs X
GAD-7 questionnaire X X X
Time (min) 20 60 300 20 20 300 20 20 20 10 10 10 10 10 10 10 60 10 10 10 10 10 10 10 60