Table 1.

Schedule of events

Procedure	Screening	Visit 1 (Day 0) Baseline	Visit 2 (Day 30)	Visit 3 (Day 60)	Visit 4 (Day 90) Final visit	Follow-Up visit (At least 15 days from the last visit)
Informed consent	X
Medical history	X
Physical examination	X	X	X	X	X
Demographicsa	X	X	X	X	X
Vital Signs	X	X	X	X	X
Haematology	X				X
Serum chemistry	X				X
Myeloperoxidaseb		X			X
Urine pregnancy testc	X
Randomisation		X
Investigational product dispensing		X	X	X
Gastrointestinal discomfort questionnaire		X	X	X	X
Irritable bowel syndrome quality of life questionnaire		X	X	X	X
HAM-D scale		X	X	X	X
MADRS		X	X	X	X
CGI-I & CGI-S		X	X	X	X
CES-D		X	X	X	X
Dementia checklist		X	X	X	X
Return of unused IP			X	X	X
Adverse events		X	X	X	X	X
Concomitant medications	X	X	X	X	X	X

HAM-D, Hamilton Rating Scale for Depression; MADRS, Montgomery–Asberg Depression Rating Scale; CGI-I & CGI-S, Clinical Global Impression-Improvement Rating Scale and Clinical Global Impression Severity Rating Scale; CES-D, Center for Epidemiological Studies Depression Scale.

^aAge at screening only.

^bOnly for randomised subjects.

^cUrine pregnancy test at screening and on early termination, if any.