Table 3. Adverse events (AEs) and serious adverse events (SAEs) in 6 to 20 years-old.

	BK-SE36		Saline (mL)
	BKSE1.0	BKSE0.5	1.0	0.5
	[n = 33] (%)	[n = 33] (%)	[n = 9] (%)	[n = 9] (%)
Local AEs
Induration	32 (97.0)	31 (93.9)	0	0
Pain	11 (33.3)	6 (18.2)	0	0
Tenderness	17 (51.5)	17 (51.5)	1 (11.1)	0
Swelling	0	0	0	0
Erythema	4 (12.1)	1 (3.0)	0	0
Redness	0	0	0	0
Hyperpigmentation	1 (3.0)	0	0	0
Hyperemia	1 (3.0)	0	0	0
Systemic AEs
Fever (≥37.5°C)	1 (3.0)	1 (3.0)	0	0
Headache	0	0	1 (11.1)	0
High aspartate aminotransferase (AST)	0	1 (3.0)	0	0
High alanine aminotransferase (ALT)	0	1 (3.0)	0	0
Serious AEs	0	0	0	0

For local AEs, number and percentages refer to the number of subjects with at least one upper arm experiencing a specified symptom; however, subjects can experience the same symptom in both arms.

Abnormally high AST and ALT were observed in a 6 year-old subject right after treatment for lower respiratory tract infection.