Table 6.

Commonly reported treatment-related treatment-emergent adverse events (preferred terms in ≥ 5% of participants for any treatment) (safety analysis set)

Preferred term relationship	A: Dronabinol 5 mg fasted (N = 121) n (%) E	B: Acetazolamide 250 mg fasted (N = 119) n (%) E	C: IHL-42X fasted (N = 122) n (%) E	D: IHL-42X fed (N = 119) n (%) E	Overall (N = 125) n (%) E
Participants with ≥ 1 TEAE
Possibly related	38 (31.4%) 57	22 (18.5%) 26	37 (30.3%) 65	46 (38.7%) 71	83 (66.4%) 219
Probably related	23 (19.0%) 38	5 (4.2%) 5	26 (21.3%) 38	29 (24.4%) 43	53 (42.4%) 124
Definitely related	3 (2.5%) 3	0	8 (6.6%) 11	4 (3.4%) 5	13 (10.4%) 19
Somnolence
Possibly related	17 (14.0%) 18	6 (5.0%) 6	12 (9.8%) 13	17 (14.3%) 17	36 (28.8%) 54
Probably related	5 (4.1%) 5	4 (3.4%) 4	5 (4.1%) 5	7 (5.9%) 7	15 (12.0%) 21
Definitely related	1 (0.8%) 1	0	1 (0.8%) 1	1 (0.8%) 1	3 (2.4%) 3
Headache
Possibly related	7 (5.8%) 7	9 (7.6%) 9	9 (7.4%) 9	11 (9.2%) 12	27 (21.6%) 37
Probably related	1 (0.8%) 1	0	1 (0.8%) 1	0	2 (1.6%) 2
Definitely related	0	0	0	0	0
Dizziness
Possibly related	3 (2.5%) 3	2 (1.7%) 2	4 (3.3%) 4	8 (6.7%) 8	16 (12.8%) 17
Probably related	6 (5.0%) 6	0	4 (3.3%) 4	4 (3.4%) 4	11 (8.8%) 14
Definitely related	1 (0.8%) 1	0	0	0	1 (0.8%) 1
Euphoric mood
Possibly related	0	0	2 (1.6%) 2	0	2 (1.6%) 2
Probably related	13 (10.7%) 13	0	9 (7.4%) 9	13 (10.9%) 13	24 (19.2%) 35
Definitely related	1 (0.8%) 1	0	6 (4.9%) 7	4 (3.4%) 4	9 (7.2%) 12

Treatment-related TEAEs were defined as TEAEs evaluated as possibly, probably, or definitely related to IP

E number of events, IP investigational product, N number of participants in group, n number of participants with observations, TEAE treatment-emergent adverse event