Table 3.

Summary of AEs in the phase 2b trial

		Placebo (n=180)	RTB101 (n=176)
Any AE		149 (83%)	147 (84%)
AE by maximum severity*
	Mild	129 (72%)	131 (74%)
	Moderate	73 (41%)	67 (38%)
	Severe	14 (8%)	10 (6%)
Study-drug related AE		39 (22%)	35 (20%)
Serious AE		14 (8%)	8 (5%)
AE leading to study drug discontinuation		10 (6%)	9 (5%)
AE leading to study withdrawal		1 (<1%)	2 (1%)
AE leading to death		1 (<1%)	1 (<1%)

Data are n (%). Table shows patients with at least one AE. AE=adverse event.

^*Mild defined as usually transient in nature and generally not interfering with normal activities; moderate defined as sufficiently discomforting to interfere with normal activities; and severe defined as preventing normal activities.