Table 2.
Visits | Visit 01 (Day 0)∗ | Visit 02 (Day 1)† | Visit 03 (Day 40)‡ | Visit 04 (Day 80)§ | Visit 05 (Day 90)|| | Visit 06¶ |
Informed consent | √ | |||||
Demography | √ | |||||
Inclusion/exclusion criteria | √ | |||||
Vital signs | √ | √ | √ | √ | √ | √ |
Physical examination | √ | √ | √ | √ | √ | |
Medical/surgical history | √ | |||||
Pregnancy test | √ | |||||
Rome IV criteria | √ | |||||
Laboratory tests | √ | √ | ||||
Upper GI endoscopy | √ | √ | ||||
IP Dispensing | √ | √ | ||||
Issue Dairy card | √ | √ | ||||
Concomitant medicationschecking | √ | √ | √ | √ | √ | |
IBS-SSS Questionnaire and (VAS) | √ | √ | √ | √ | ||
Bristol stool form scale (BSFC) | √ | √ | ||||
DSFQ | √ | √ | √ | √ | √ | |
Compliance check | √ | √ | √ | |||
AE/SAE assessment | √ | √ | √ | √ | √ |