Table 5.

Adverse Events in Two or More Participants in Any Single Treatment Group at Any Study Visit (Observed Cases)

	Week 13		Week 17		Week 21
	Basic n = 49 (%)	Augmented n = 54 (%)	Basic n = 42 (%)	Augmented n = 50 (%)	Basic n = 41 (%)	Augmented n = 47 (%)
Headache	5 (10)	6 (11)
Difficulty initiating sleep	7 (14)	2 (4)	4 (10)	2 (4)	2 (5)
Cough	4 (8)	2 (4)	3 (7)	3 (6)	2 (5)	2 (4)
Appetite increase		6 (11)	2 (5)
Anxiety	2 (4)	3 (6)
Enuresis		3 (6)	2 (5)	2 (4)
Musculoskeletal injury	2 (4)
Behavioral, NOS	2 (4)
Rhinorrhea		3 (6)
Sedation		3 (6)	4 (10)		2 (5)
Appetite decrease			3 (7)
Constipation	2 (4)
Fever	2 (4)			3 (6)
Nasal congestion		2 (4)
Otitis media	2 (4)
Pharyngitis (strep)	2 (4)
Oral/dental injury			2 (5)
Bronchopulmonary congestion				2 (4)

NOS, not otherwise specified.