TABLE IV.

Safety data

	Active (n = 13)		Placebo (n = 7)		P value
Doses per child, median (range)	177 (155-242)		171 (152-199)		.05
Total doses	2437		1193		NA
Symptom/treatment	No. (%) of total doses	Percentage of doses with reaction/treatment per child, median (range)	No. (%) of total doses	Percentage of doses with reaction/treatment per child, median (range)
Total reactions	1107 (45.4)	35 (1-95)	134 (11.2)	1 (0-53)	.02
Local symptoms	870 (35.7)	16 (1-90)	104 (8.7)	1 (0-53)	.006
Gastrointestinal	458 (18.7)	2 (0-93)	16 (1.3)	0 (0-3)	.02
Lower respiratory	198 (8.1)	1 (0-82)	28 (2.3)	1 (0-12)	.3
Skin	22 (0.9)	0 (0-8)	1 (0.1)	0 (0-1)	.1
Multiple systems	29 (1.2)	1 (0-7)	0	0	.01
Eczema flare	1 patient	NS	1 patient	NS	NS
Diphenhydramine	249 (10.2)	1 (0-58)	14 (1.1)	1 (0-6)	.3
Albuterol	21 (0.9)	0 (0-4)	2 (0.2)	0 (0-1)	.2
Epinephrine	4 (0.2)	0 (0-1)	0	0	.1

NA, Not applicable; NS, not significant.