TABLE 2.

Overall Summary of Treatment-Emergent Adverse Events (Safety Analysis Set).

Participants With	RE104 5 mg (N=6) n (%) E	RE104 10 mg (N=6) n (%) E	RE104 20 mg (N=6) n (%) E	RE104 30 mg (N=9) n (%) E	RE104 35 mg (N=6) n (%) E	RE104 40 mg (N=3) n (%) E	Pooled RE104 (N=36) n (%) E	Pooled Placebo (N=12) n (%) E	All Participants (N=48) n (%) E
≥1 TEAE	2 (33.3) 3	2 (33.3) 4	2 (33.3) 5	8 (88.9) 30	5 (83.3) 31	3 (100) 16	22 (61.1) 89	4 (33.3) 5	26 (54.2) 94
≥1 procedure- related TEAE	0	0	0	1 (11.1) 1	0	0	1 (2.8) 1	0	1 (2.1) 1
≥1 serious TEAE	0	0	0	0	0	0	0	0	0
≥1 severe TEAE	0	0	0	0	1 (16.7) 1	1 (33.3) 1	2 (5.6) 2	0	2 (4.2) 2
≥1 treatment -related TEAE	1 (16.7) 2	2 (33.3) 4	2 (33.3) 5	8 (88.9) 25	5 (83.3) 27	3 (100) 16	21 (58.3) 79	2 (16.7) 2	23 (47.9) 81
TEAE leading to study withdrawal	0	0	0	0	0	0	0	0	0

TEAEs were defined as adverse events that commenced at or after the study drug administration. Treatment-related AEs were defined as AEs where the relationship to study drug was reported as ‘Related’ or is missing. Participants who experienced multiple events within a category are counted only once in the specific category (n); however, each instance of the event is counted (E). Percentages (%) are calculated based on the number of participants in the analysis set (N). Percentage (%) of participants (n) in each category are calculated based on the number of participants in the analysis set (N).

AE indicates adverse event; E, number of adverse events; N, number of participants; TEAE, treatment-emergent adverse event.