Table 3.

Subjects allocation per trial arm and subgroup and baseline characteristics

			Gender		Age		BMI (kg/m2)		GI symp. DTS a
Cohort	Treatment	n	Males (n)	Females (n)	Range	Median	Range	Median	Mean (± SEM)
Total cohort (n = 80)	EpiCor	40	7	33	20–69	50	18–33	24	7.20 ± 0.56
	Placebo	40	6	34	21–65	45	18–35	24	6.56 ± 0.46
Severe (n = 55)	EpiCor	28	5	23	24–66	48	18–33	24	8.68 ± 0.60
	Placebo	27	3	24	21–65	44	18–33	24	8.08 ± 0.42
Moderate (n = 25)	EpiCor	12	2	10	20–69	57	19–33	23	3.74 ± 0.31
	Placebo	13	3	10	23–63	52	20–35	22	3.41 ± 0.32

Legend: BMI, body mass index; GI, gastrointestinal

^aAverage of daily total scores (DTS) obtained after 2-week run-in on GI symptoms. This score was used to allocate subjects within the two subgroups (severe: GI symptoms ≥ 5 and moderate: GI symptoms <5)