Table 4 |.

Safety and tolerability data

	Placebo (n = 48)	Aramchol 400 mg (n = 101)	Aramchol 600 mg (n = 98)
Overall treatment withdrawal rate, n (%)	7 (14.6)	11 (10.9)	10 (10.2)
Treatment withdrawal due to AE, n (%)	2 (4.2)	3 (3)	4 (4.1)
Participants with serious AE, n (%)	6 (12.5)	9 (8.9)	9 (9.2)
Participants with severe AE, n (%)	5 (10.4)	7 (6.9)	6 (6.1)
Participants with any AE, n (%)	33 (68.8)	75 (74.3)	77 (78.6)
Gastrointestinal disorders
Constipation, n (%)	6 (12.5)	5 (5)	8 (8.2)
Nausea, n (%)	6 (12.5)	10 (9.9)	9 (9.2)
Nervous system disorders
Headache, n (%)	6 (12.5)	14 (13.9)	15 (15.3)
Skin disorders
Pruritus, n (%)	3 (6.3)	7 (6.9)	11 (11.2)
Infections
UTI, n (%)	3 (6.3)	15 (14.9)	13 (13.3)

AEs with an incidence ≥10% in any treatment arm are presented by system organ class and preferred term. No deaths were reported during the study.