TABLE 6.

AEs during complete follow-up period and for 1 month after treatments

AE	Complete follow-up period (3-24 mo)				1 mo after treatment
	Placebo group		SP group		Placebo group		SP group
	%	No. of events	%	No. of events	%	No. of events	%	No. of events
Total	100.0	4,506	100.0	4,516	100.0	522	100.0	490
Skin	11.5	519	9.8	442	7.7	40	4.9	24
Infection	4.2	189	4.3	193	1.5	8	1.6	8
Rash	1.9	85	1.7	75	2.3	12	1.0	5
Scabies	4.0	182	2.8b	128	2.7	14	1.0	5
Gastrointestinal tract	40.3	1,815	40.9	1,846	42.3	221	42.4	208
Diarrhea	11.7	525	12.0	544	18.6	97	16.9	83
Gastroenteritis	23.8	1,071	23.8	1,074	19.5	102	21.4	105
Respiratory tract	29.0	1,306	30.4	1,371	32.0	167	35.7	175
URTIa	23.4	1,054	24.6	1,110	26.1	136	30.8	151
Pneumonia	2.2	98	2.5	112	2.5	13	2.9	14
Otitis	3.4	152	3.8	172	4.8	25	3.5	17
Conjunctivitis	3.5	157	3.8	172	2.1	11	2.2	11
Other	12.4	557	11.4	513	11.1	58	11.2	55

^aURTI, upper respiratory tract infection.

^bP < 0.0001.