Trial Outcomes & Findings for Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth (NCT NCT00109590)

NCT ID: NCT00109590

Last Updated: 2021-11-05

Results Overview

The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL \<500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL \<500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 175 participants
• Primary outcome timeframe: within 8 weeks postpartum.
• Results posted on: 2021-11-05

Participant Flow

Study participants were enrolled at seven IMPAACT affiliated sites in Thailand. Between June 9, 2006 and June 30, 2008, 175 participants enrolled in the study.

The study recruited HIV infected pregnant women who were >= 18 years of age,>=28 to <38 weeks gestation, who did not plan to start antiretroviral treatment within eight weeks following delivery, not planning to breastfeed and had CD4+ count >250 cells/mm3. Women were randomized in approximately equal numbers to one of three treatment arms.

Participant milestones

Measure	Arm A : LPV/r x 7d Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum,\> Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally once daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Study STARTED	57	58	60
Overall Study RECEIVED TREATMENT	56	56	57
Overall Study COMPLETED	55	56	56
Overall Study NOT COMPLETED	2	2	4

Reasons for withdrawal

Measure	Arm A : LPV/r x 7d Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum,\> Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally once daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Overall Study Lost to Follow-up	1	0	1
Overall Study Never Started Treatment	1	2	3

Baseline Characteristics

Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

Baseline characteristics by cohort

Measure	Arm A : LPV/r x 7d n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=57 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.	Total n=169 Participants Total of all reporting groups
Age, Continuous	27 years STANDARD_DEVIATION 6 • n=5 Participants	28 years STANDARD_DEVIATION 5 • n=7 Participants	27 years STANDARD_DEVIATION 5 • n=5 Participants	28 years STANDARD_DEVIATION 5 • n=4 Participants
Age, Customized 18 to < 30years	34 participants n=5 Participants	35 participants n=7 Participants	38 participants n=5 Participants	107 participants n=4 Participants
Age, Customized >=30 to < 45 years	21 participants n=5 Participants	21 participants n=7 Participants	19 participants n=5 Participants	61 participants n=4 Participants
Age, Customized >= 45 years	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	56 Participants n=7 Participants	57 Participants n=5 Participants	169 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Gestational Age at Entry	32 weeks n=5 Participants	31 weeks n=7 Participants	31 weeks n=5 Participants	31 weeks n=4 Participants
Duration of ZDV during pregnancy - At Entry	3 weeks n=5 Participants	2 weeks n=7 Participants	2 weeks n=5 Participants	3 weeks n=4 Participants
Duration of ZDV during pregnancy - At Delivery	10 weeks n=5 Participants	11 weeks n=7 Participants	10 weeks n=5 Participants	10 weeks n=4 Participants
CD4 cell count at entry	431 cells/uL n=5 Participants	413 cells/uL n=7 Participants	481 cells/uL n=5 Participants	456 cells/uL n=4 Participants
CD4 cell count at delivery	484 cells/uL n=5 Participants	517 cells/uL n=7 Participants	566 cells/uL n=5 Participants	513 cells/uL n=4 Participants
Plasma HIV RNA at entry	3.48 log10 copies/mL n=5 Participants	3.52 log10 copies/mL n=7 Participants	3.54 log10 copies/mL n=5 Participants	3.49 log10 copies/mL n=4 Participants
Plasma HIV-RNA at delivery	3.63 log10 copies/mL n=5 Participants	3.36 log10 copies/mL n=7 Participants	3.48 log10 copies/mL n=5 Participants	3.48 log10 copies/mL n=4 Participants

PRIMARY outcome

Timeframe: within 8 weeks postpartum.

Population: All women who started treatment were included in an intention-to-treat analysis.

The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.

Outcome measures

Measure	Arm A : LPV/r x 7d n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=57 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).	7.1 percent of participants Interval 2.0 to 17.3	12.5 percent of participants Interval 5.2 to 24.1	5.3 percent of participants Interval 1.1 to 14.6

PRIMARY outcome

Timeframe: at Day 10 or Week 6 postpartum.

Population: All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.

Outcome measures

Measure	Arm A : LPV/r x 7d n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=57 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma	3.6 percent of participants Interval 0.5 to 12.3	7.1 percent of participants Interval 2.0 to 17.3	5.3 percent of participants Interval 1.1 to 14.6

PRIMARY outcome

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Population: 18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.

Outcome measures

Measure	Arm A : LPV/r x 7d n=16 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=14 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)	99.7 ug*hr/mL Interval 66.3 to 180.5	NA ug*hr/mL Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the AUC and Cmax.	—

PRIMARY outcome

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Population: 18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.

Outcome measures

Measure	Arm A : LPV/r x 7d n=16 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=14 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .	11.2 ug/mL Interval 8.0 to 17.5	NA ug/mL Only 3 samples were collected at 30 days postpartum for PK assessment (pre-dose, 2 hours and 4 hours post-dose) and with these limited number of samples it was not possible to have a good estimate of the Cmax.	—

PRIMARY outcome

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Population: 18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.

Outcome measures

Measure	Arm A : LPV/r x 7d n=16 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=14 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).	6.08 ug/mL Interval 2.34 to 13.64	9.17 ug/mL Interval 5.28 to 14.97	—

PRIMARY outcome

Timeframe: Within 72 hours postpartum and during the first 30 days postpartum

Population: 18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.

Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.

Outcome measures

Measure	Arm A : LPV/r x 7d n=16 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=14 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).	10.78 ug/mL Interval 8.01 to 16.72	12.96 ug/mL Interval 8.78 to 21.37	—

SECONDARY outcome

Timeframe: at Day 10 or Week 6 postpartum.

Population: Includes only the Subgroup of women with Plasma HIV RNA \>= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).

The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.

Outcome measures

Measure	Arm A : LPV/r x 7d n=41 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=42 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=43 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry	4.9 percent of participants Interval 0.6 to 16.6	9.5 percent of participants Interval 2.7 to 22.6	7.0 percent of participants Interval 1.5 to 19.1

SECONDARY outcome

Timeframe: At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).

Population: All women who started treatment were included in an intention-to-treat analysis

Outcome measures

Measure	Arm A : LPV/r x 7d n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=57 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations. The proportion of women with new ZDV resistance	0 percent of participants	1.78 percent of participants	0 percent of participants
The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations. The proportion of women with new ddI resistance	0 percent of participants	0 percent of participants	0 percent of participants
The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations. The proportion of women with new LPV/r resistance	0 percent of participants	0 percent of participants	0 percent of participants

SECONDARY outcome

Timeframe: After start of study Treatment (postpartum)

Population: All women who started treatment were included in an intention-to-treat analysis.

Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.

Outcome measures

Measure	Arm A : LPV/r x 7d n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=56 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=57 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Number of Women With Grade >=3 Events After Start of Study Treatment	2 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: within 72 weeks postpartum

Population: amongst the participants who developed resistance within 8 weeks postpartum

Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.

Outcome measures

Measure	Arm A : LPV/r x 7d n=3 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=7 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=3 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum. OLA in plasma samples	0 participants	0 participants	0 participants
Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum. OLA in PBMC	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: 24 weeks postpartum

Population: Amongst the infants who became HIV-infected.

Resistance mutations as identified by consensus sequencing or OLA

Outcome measures

Measure	Arm A : LPV/r x 7d NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=1 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=1 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Resistance Mutations in HIV Infected Infants	—	0 participants	0 participants

SECONDARY outcome

Timeframe: at 24 weeks postpartum

Population: The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.

Outcome measures

Measure	Arm A : LPV/r x 7d n=54 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.	Arm B : no LPV/r n=55 Participants NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.	Arm C: LPV/r x 30d n=54 Participants NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight \<60 kg) or 400 mg orally daily (if body weight \>= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
Median HIV-1 Viral Load at 24 Weeks Postpartum in Women	4.3 log10 copies/mL Interval 1.7 to 5.7	3.9 log10 copies/mL Interval 1.7 to 5.3	4.0 log10 copies/mL Interval 1.7 to 5.2

Adverse Events

Mother: LPV/r x 7d

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Mother: no LPV/r

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Mother: LPV/r x 30d

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Infant: LPV/r x 7d

Serious events: 34 serious events

Other events: 48 other events

Deaths: 0 deaths

Infant: no LPV/r

Serious events: 32 serious events

Other events: 51 other events

Deaths: 0 deaths

Infant: LPV/r x 30d

Serious events: 33 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mother: LPV/r x 7d n=56 participants at risk NVP 200 mg orally, single dose at onset	Mother: no LPV/r n=56 participants at risk ZDV \& ddI x 30d	Mother: LPV/r x 30d n=57 participants at risk ZDV, ddI, LPV/r x 30d	Infant: LPV/r x 7d n=56 participants at risk NVP 200 mg orally, single dose at onset	Infant: no LPV/r n=57 participants at risk ZDV \& ddI x 30d	Infant: LPV/r x 30d n=57 participants at risk ZDV, ddI, LPV/r x 30d
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	30.4% 17/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	14.0% 8/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	17.5% 10/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Blood and lymphatic system disorders Neutropenia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Blood and lymphatic system disorders Neutropenia neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders ABO haemolytic disease of newborn	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Congenital hypothyroidism	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Fallot's tetralogy	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Phimosis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Pulmonary artery stenosis congenital	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Eye disorders Conjunctival hyperaemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Abdominal pain	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Constipation	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Diarrhoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Duodenal stenosis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
General disorders Pyrexia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Immune system disorders Allergy to arthropod bite	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Nasopharyngitis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Oral candidiasis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Pneumonia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Rhinitis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Upper respiratory tract infection	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Alanine aminotransferase increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Aspartate aminotransferase increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	17.9% 10/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	19.3% 11/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	17.5% 10/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood bicarbonate decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood calcium increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood creatine increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood creatinine increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood glucose decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood potassium increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood sodium decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood sodium increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood thyroid stimulating hormone increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Haemoglobin decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Heart rate increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Liver function test abnormal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Neutrophil count decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Platelet count decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations White blood cell count increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Neonatal hyponatraemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Umbilical granuloma	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Renal and urinary disorders Haematuria	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Renal and urinary disorders Proteinuria	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Neonatal tachypnoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Rash	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).

Other adverse events

Measure	Mother: LPV/r x 7d n=56 participants at risk NVP 200 mg orally, single dose at onset	Mother: no LPV/r n=56 participants at risk ZDV \& ddI x 30d	Mother: LPV/r x 30d n=57 participants at risk ZDV, ddI, LPV/r x 30d	Infant: LPV/r x 7d n=56 participants at risk NVP 200 mg orally, single dose at onset	Infant: no LPV/r n=57 participants at risk ZDV \& ddI x 30d	Infant: LPV/r x 30d n=57 participants at risk ZDV, ddI, LPV/r x 30d
Blood and lymphatic system disorders Anaemia	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	19.6% 11/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	26.3% 15/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	21.1% 12/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Blood and lymphatic system disorders Anaemia neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Ear and labyrinth disorders Ear pain	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Eye disorders Conjunctival discolouration	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Eye disorders Conjunctivitis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Eye disorders Eye discharge	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Abdominal distension	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Diarrhoea	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Diarrhoea neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Gastrointestinal disorders Vomiting	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
General disorders Pyrexia	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	16.1% 9/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	14.0% 8/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	16.1% 9/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	17.5% 10/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	28.1% 16/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
General disorders Secretion discharge	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Hepatobiliary disorders Jaundice	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	14.3% 8/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	19.3% 11/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Immune system disorders ABO incompatibility	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Bronchitis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Nasopharyngitis	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.3% 7/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Pharyngitis	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Postoperative wound infection	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Tonsillitis	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Upper respiratory tract infection	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Infections and infestations Vulvovaginal candidiasis	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Alanine aminotransferase increased	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Aspartate aminotransferase increased	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.5% 7/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood bicarbonate abnormal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.3% 7/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood bilirubin increased	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood creatinine increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood glucose abnormal	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood glucose decreased	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood glucose increased	14.3% 8/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.3% 7/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood potassium increased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Blood sodium decreased	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.5% 7/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.3% 7/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Cardiac murmur	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Haemoglobin abnormal	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	41.1% 23/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	26.3% 15/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	35.1% 20/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Haemoglobin decreased	26.8% 15/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	28.6% 16/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	36.8% 21/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	39.3% 22/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	31.6% 18/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	38.6% 22/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Neutrophil count decreased	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	14.0% 8/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Investigations Platelet count decreased	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Hypothermia neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	25.0% 14/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	21.1% 12/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	26.3% 15/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Pregnancy, puerperium and perinatal conditions Umbilical granuloma	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.5% 6/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Reproductive system and breast disorders Vaginal discharge	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Cough	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.5% 7/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.5% 7/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	19.3% 11/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Neonatal tachypnoea	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	12.5% 7/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	10.7% 6/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	14.3% 8/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	19.3% 11/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Dermatitis allergic	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.0% 4/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.5% 2/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Papule	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	3.6% 2/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Rash	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.4% 3/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.9% 5/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	1.8% 1/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).
Vascular disorders Pallor	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	0.00% 0/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	7.1% 4/56 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	5.3% 3/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).	8.8% 5/57 • Adverse Events (AEs) were required to be reported for the entire duration for an individual subject i.e. from study enrollment until study completion or discontinuation of the subject from study participation for any reason. Expedited adverse event (EAE) reporting was at the DAIDS Intensive level: all deaths, congenital anomalies, fetal losses, or significant disabilities; also, suspected adverse drug reactions of grade \>=3 for mothers or grade \>=1 for infants (grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death per the 12/2--4 DAIDS AE Grading Table).

Additional Information

Melissa Allen, Director, IMPAACT Operations Center

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: mallen@fhi360.org

Results disclosure agreements

• Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights".
• Publication restrictions are in place

Restriction type: OTHER