Table 3. Serious Adverse Events (SAE) and AEs (Double-Blind Week 12 to Open-Label Week 24).

Adverse event	Participants, No. (%)
	Double-blind (12 weeks)				Open label 24 weeks
	SAE		AE		SAE		AE among all participants (n = 172)
	Related	Unrelated	Drug (n = 92)	Placebo (n = 98)	Related	Unrelated	Total AEs
			Total AEs	Total AEs
Infection (including colds, flu, croup, ear, sinus, and other)	0	0	62 (22)	72 (26)	0	0	15 (9)
Gastrointestinal (including vomiting, constipation, diarrhea, flatulence, and upset)	0	0	41 (15)	63 (23)	0	0	6 (3)
Respiratory (cough, nasal congestion, asthma, and sore throat)	0	0	0	17 (6)	0	0	3 (2)
Psychiatric (sleep disturbances, irritability, repetitive behaviors, aggression, and anxiety)	0	0	10 (4)	15 (5)	0	0	4 (2)