Items | Before enrolment (weeks) –4 to 0 | Intervention period (weeks) 1–6 | End of 6-week treatment (weeks) | Follow-up (weeks) 7–12 | End of 12-week follow-up (weeks) | Follow-up (weeks) 13–18 | End of 18-week follow-up (weeks) | |
---|---|---|---|---|---|---|---|---|
Recruitment | × | |||||||
Enrolment | × | |||||||
Inclusion criteria | × | |||||||
Exclusion criteria | × | |||||||
Informed consent | × | |||||||
Basic characteristic variables | × | |||||||
Randomization and allocation concealment | × | |||||||
Primary outcomes | AR | × | × | × | × | × | × | |
Secondary outcomes | SSS | × | × | × | × | |||
BSS | × | × | × | × | ||||
IBS-QOL | × | × | ||||||
HADS | × | × | ||||||
Safety outcome | × | × | × | |||||
Statistical analysis | × | × | × |