Table 7.

Summary of subjects with any AE by preferred term (safety set)

	Number (%) of subjects
Preferred term	NBMI 100 mg (n = 13)	NBMI 300 mg (n = 11)	Placebo (n = 12)	Total (n = 36)
Number of subjects with any AE*	6 (46.2%)	5 (45.5%)	8 (66.7%)	19 (52.8%)
Headache	5 (38.5%)	3 (27.3%)	4 (33.3%)	12 (33.3%)
Abdominal pain upper	1 (7.7%)	1 (9.1%)	2 (16.7%)	4 (11.1%)
Abdominal pain		1 (9.1%)	2 (16.7%)	3 (8.3%)
Diarrhoea	1 (7.7%)		1 (8.3%)	2 (5.6%)
Somnolence	1 (7.7%)		1 (8.3%)	2 (5.6%)
Animal bite		1 (9.1%)		1 (2.8%)
Arthralgia			1 (8.3%)	1 (2.8%)
Back pain			1 (8.3%)	1 (2.8%)
Ear pain	1 (7.7%)			1 (2.8%)
Gastroenteritis	1 (7.7%)			1 (2.8%)
Ingrowing nail	1 (7.7%)			1 (2.8%)
Insomnia			1 (8.3%)	1 (2.8%)
Lip dry			1 (8.3%)	1 (2.8%)
Oropharyngeal pain			1 (8.3%)	1 (2.8%)
Vertigo			1 (8.3%)	1 (2.8%)