Table 2 Schedule of events

Informed consent

X

Medical history

X

Physical examination

X

X

X

X

X

Demographics^a

X

X

X

X

Vital signs^b

X

X

X

X

X

Hematology

X

X

Serum chemistry

X

X

Stool test for consistency

X

X

Urine pregnancy test^c

X

Randomization

X

IP dispensing and dosing

X

X

X

VAS assessment

X

X

X

X

Gastrointestinal discomfort questionnaire

X

X

X

X

Bristol stool score

X

X

X

X

Physician’s global assessment

X

X

X

Irritable bowel syndrome (IBS) quality of life questionnaire

X

X

X

X

Adverse events (AEs)

X

X

X

X

X

Concomitant medications

X

X

X

X

X