Table 2.

Primary and secondary treatment outcomes (per-protocol population)^*

		Procaine benzylpenicillin and gentamicin (n=747)	Amoxicillin and gentamicin (n=751)	Procaine benzylpenicillin, gentamicin, and amoxicillin (n=753)	Risk difference†(95% CI)	Risk difference‡(95% CI)
Primary outcome
Treatment failure within 7 days of enrolment		90 (12%)	76 (10%)	99 (13%)	−1·9 (−5·1 to 1·3)	1·1 (−2·3 to 4·5)
Initial reason for treatment failure
	Death	6	4	6	..	..
	Admission	17	13	21	..	..
	Clinical deterioration	14	12	17	..	..
	New sign on or after day 3	8	11	3	..	..
	Persistence of signs at day 4	22	12	28	..	..
	Recurrence of signs on or after day 5	13	15	16	..	..
	Persistence of signs at day 8	0	0	0	..	..
	Serious adverse event	1	1	0	..	..
	Antibiotic change because of infectious comorbidity	9	8	8	..	..
Secondary outcomes
Admission within 7 days of enrolment		26 (3%)	20 (3%)	30 (4%)	−0·8 (−2·6 to 0·9)	0·5 (−1·4 to 2·4)
Died within 7 days of enrolment		11 (1%)	7 (1%)	10 (1%)	−0·5 (−1·6 to 0·6)	−0·1 (−1·3 to 1·0)
Died at any time before day 15 visit		13 (2%)	9 (1%)	12 (2%)	−0·5 (−1·8 to 0·7)	−0·1 (−1·4 to 1·1)
Not classified as treatment failure with follow-up on day 11 or day 15		642 (86%)	661 (88%)	643 (85%)	..	..
Admission at any time between day 8 and day 15 visits§		6 (1%)	2 (<1%)	1 (<1%)	..	..
Died any time between day 8 and day 15 visits§		0	1 (<1%)	2 (<1%)	..	..
Non-fatal relapse at any time between day 8 and day 15 visits§		20 (3%)	9 (1%)	6 (1%)	−1·8 (−3·4 to −0·1)	−2·2 (−3·7 to −0·6)

Data are number of children (%), unless otherwise stated.

^*Secondary outcomes for all randomly allocated infants are presented in the appendix (p 4).

^†Difference between amoxicillin and gentamicin, and procaine benzylpenicillin and gentamicin.

^‡Difference between procaine benzylpenicillin, gentamicin, and amoxicillin, and procaine benzylpenicillin and gentamicin.

^§Denominator was children not classified as treatment failures with follow-up to day 11 or day 15.