Table 1.

Target number of mother-infant pairs, women or infants to be enrolled in each PROMISE component and protocol version

PROMISE Component	1077BF	1077FF
Antepartum Randomization	3,400 pairsb	1,000 pairsb
Late Presenters Registration	2,500 pairsa	0
Postpartum Randomization
From Antepartum Componentb	3,100 pairs	0
From Late Presenters Registration	1,550 pairs	0
Maternal Health Randomization
After deliveryb	100 womenc	475 women
After BF perinatal transmission risk ceasesb	2,100 women	0

^a.Initial enrollment in PROMISE (in italics). It was projected that a total of 2,500 late presenting mother-infant pairs would need to be registered to the Late Presenters registration in order to identify 1,550 late presenting mother-infant pairs eligible for the Postpartum randomization.

^b.For 1077BF and 1077FF, the numbers shown are only the numbers of pairs, women or infants who were projected to meet eligibility criteria and agree to be randomized in that component. In addition, all women and infants who participated in a previous PROMISE randomization but were not eligible for or did not agree to be randomized in a subsequent randomization continued to be followed on-study as a comparison group.

^c.Projected number of women in the Antepartum triple antiretroviral therapy arm ineligible for the Postpartum randomization due to infant ineligibility or stillbirth but still eligible for the Maternal Health randomization.