Table 4.

Adverse Events Occuring in≥5% of Participants

		Double-blind dosing period
MedDRA System Preferred Term, n (%)	Open-label period n=26	Placebo n=22	MPH-MLR n=21
Abdominal pain	3 (11.5)	1 (4.5)	2 (9.5)
Vomiting	3 (11.5)	0 (0)	1 (4.8)
Pyrexia	4 (15.4)	0 (0)	2 (9.5)
Influenza	2 (7.7)	0 (0)	0 (0)
Otitis media	3 (11.5)	0 (0)	0 (0)
Respiratory tract infection	2 (7.7)	0 (0)	0 (0)
Rhinitis	2 (7.7)	1 (4.5)	1 (4.8)
Sinusitis	2 (7.7)	0 (0)	0 (0)
Decreased appetite	6 (23.1)	0 (0)	0 (0)
Headache	6 (23.1)	0 (0)	3 (14.3)
Insomnia	8 (30.8)	1 (4.5)	0 (0)
Somnolence	2 (7.7)	0 (0)	0 (0)
Emotional distress	2 (7.7)	0 (0)	1 (4.8)
Irritability	5 (19.2)	1 (4.5)	0 (0)
Mood swings	2 (7.7)	0 (0)	0 (0)
Cough	4 (15.4)	0 (0)	0 (0)
Nasal congestion	3 (11.5)	0 (0)	0 (0)
Rhinorrhea	3 (11.5)	0 (0)	0 (0)

		Double-blind dosing period
MedDRA System Organ Class, n (%)	Open-label period n=26	Placebo n=22	MPH-MLR n=21
Rash	2 (7.7)	0 (0)	1 (4.8)

MedDRA, Medical Dictionary for Regulatory Activities; MPH-MLR, extended-release multilayer bead methylphenidate.