Table 4.

Adverse Events

	Low-dose (n=59)		High-dose (n=53)		Placebo (n=57)
Adverse events	Event	Subject	Event	Subject	Event	Subject	PHP	PLP
Overall	13	11 (18.6%)	10	7 (13.2%)	26	13 (22.8%)	0.192	0.580
Ear and labyrinth disorders
Tinnitus	0	0	0	0	1	1 (1.8%)	1	0.491
Gastrointestinal disorders
Abdominal pain upper	0	0	0	0	1	1 (1.8%)	1	0.491
Constipation	0	0	1	1 (1.9%)	1	1 (1.8%)	1	0.491
Dry mouth	0	0	1	1 (1.9%)	0	0	0.482	NA
Irritable bowel syndrome	0	0	0	0	1	1 (1.8%)	1	0.491
Mouth ulceration	1	1 (1.7%)	1	1 (1.9%)	1	1 (1.8%)	1	1
Tongue ulceration	0	0	0	0	1	1 (1.8%)	1	0.491
General disorder
Malaise	0	0	0	0	1	1 (1.8%)	1	0.491
Infections
Tonsillitis	0	0	1	1 (1.9%)	0	0	0.482	NA
Upper respiratory tract infection	0	0	1	1 (1.9%)	0	0	0.482	NA
Biochemistry
ALT increased	0	0	0	0	1	1 (1.8%)	1	0.491
AST increased	0	0	0	0	1	1 (1.8%)	1	0.491
Immunoglobulins increased	0	0	0	0	1	1 (1.8%)	1	0.491
Musculoskeletal
Arthralgia	1	1 (1.7%)	0	0	0	0	NA	1
Myalgia	0	0	0	0	2	2 (3.5%)	0.496	0.239
Nervous system disorders
Dizziness	0	0	0	0	1	1 (1.8%)	1	0.491
Headache	2	2 (3.4%)	0	0	3	3 (5.3%)	0.244	0.677
Neuropathy peripheral	1	1 (1.7%)	0	0	0	0	NA	1
Somnolence	0	0	0	0	1	1 (1.8%)	1	0.491
Psychiatric disorders
Anxiety	1	1 (1.7%)	0	0	0	0	NA	1
Depression	0	0	1	1 (1.9%)	1	1 (1.8%)	1	0.491
Insomnia	2	2 (3.4%)	1	1 (1.9%)	2	2 (3.5%)	1	1
Mood altered	1	1 (1.7%)	0	0	0	0	NA	1
Sleep disorder	0	0	0	0	1	1 (1.8%)	1	0.491
Respiratory disorders
Cough	0	0	1	1 (1.9%)	2	1 (1.8%)	1	0.491
Skin and subcutaneous tissue disorders
Alopecia	1	1 (1.7%)	0	0	0	0	NA	1
Pruritus	2	2 (3.4%)	2	2 (3.8%)	3	3 (5.3%)	1	0.677
Rash	1	1 (1.7%)	0	0	0	0	NA	1