Trial Outcomes & Findings for Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women (NCT NCT02717494)

Last Updated: 2020-01-18

Results Overview

The number of women who experienced grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 1 and grade 4 AEs or death up to 24 weeks post-partum. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

347 participants

Primary outcome timeframe

up to 24 Weeks Post-Delivery for mother participants.

Results posted on

2020-01-18

Participant Flow

Recruitment period was from April 2016 to November 2017. Participants were recruited from medical clinics.

Of the 347 pregnant women enrolled in the study, 346 were randomized and received study vaccination. One discontinued study prior to receiving study vaccination. There were 349 infants born on the study, including 4 sets of twins. Two women discontinued study prior to delivering their child. Those children are not included in the outcome results.

Participant milestones

Participant milestones
Measure	Arm 1A (PPV-23) In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
First Intervention (Step 1) STARTED	115	115	116
First Intervention (Step 1) Were Randomized to Step 2A (PPV-23)	0	0	53
First Intervention (Step 1) Were Randomized to Step 2B (PCV-10)	0	0	53
First Intervention (Step 1) Were Enrolled in Step 3 (PCV-10)	0	0	4
First Intervention (Step 1) COMPLETED	109	108	111
First Intervention (Step 1) NOT COMPLETED	6	7	5
Second Intervention (Step 2 or Step 3) STARTED	0	0	110
Second Intervention (Step 2 or Step 3) Completed Step 2A	0	0	52
Second Intervention (Step 2 or Step 3) Completed Step 2B	0	0	50
Second Intervention (Step 2 or Step 3) Completed Step 3	0	0	4
Second Intervention (Step 2 or Step 3) COMPLETED	0	0	106
Second Intervention (Step 2 or Step 3) NOT COMPLETED	0	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1A (PPV-23) In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
First Intervention (Step 1) Lost to Follow-up	4	7	3
First Intervention (Step 1) Withdrawal by Subject	2	0	1
First Intervention (Step 1) Death	0	0	1
Second Intervention (Step 2 or Step 3) Lost to Follow-up	0	0	4

Baseline Characteristics

Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1A (PPV-23) n=115 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=115 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=116 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.	Total n=346 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 6 • n=5 Participants	27 years STANDARD_DEVIATION 6 • n=7 Participants	28 years STANDARD_DEVIATION 6 • n=5 Participants	28 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	115 Participants n=7 Participants	116 Participants n=5 Participants	346 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
Ethnicity (NIH/OMB) Hispanic or Latino	110 Participants n=5 Participants	112 Participants n=7 Participants	113 Participants n=5 Participants	335 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	57 Participants n=5 Participants	51 Participants n=7 Participants	61 Participants n=5 Participants	169 Participants n=4 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	36 Participants n=5 Participants	40 Participants n=7 Participants	28 Participants n=5 Participants	104 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Brazil	115 participants n=5 Participants	115 participants n=7 Participants	116 participants n=5 Participants	346 participants n=4 Participants
Gestational Age at Randomization	25 weeks STANDARD_DEVIATION 5 • n=5 Participants	25 weeks STANDARD_DEVIATION 5 • n=7 Participants	26 weeks STANDARD_DEVIATION 5 • n=5 Participants	26 weeks STANDARD_DEVIATION 5 • n=4 Participants
CD4% at Randomization	32 percent STANDARD_DEVIATION 9 • n=5 Participants	32 percent STANDARD_DEVIATION 9 • n=7 Participants	31 percent STANDARD_DEVIATION 9 • n=5 Participants	32 percent STANDARD_DEVIATION 9 • n=4 Participants
CD4 Count at Randomization	585 cells/microliter STANDARD_DEVIATION 257 • n=5 Participants	596 cells/microliter STANDARD_DEVIATION 243 • n=7 Participants	564 cells/microliter STANDARD_DEVIATION 297 • n=5 Participants	582 cells/microliter STANDARD_DEVIATION 266 • n=4 Participants
RNA Copies at Randomization	569 copies/mL STANDARD_DEVIATION 1825 • n=5 Participants	307 copies/mL STANDARD_DEVIATION 1278 • n=7 Participants	1144 copies/mL STANDARD_DEVIATION 7864 • n=5 Participants	674 copies/mL STANDARD_DEVIATION 4730 • n=4 Participants
Log10 RNA Copies at Randomization	1.9 log10(copies)/mL STANDARD_DEVIATION 0.6 • n=5 Participants	1.9 log10(copies)/mL STANDARD_DEVIATION 0.5 • n=7 Participants	1.8 log10(copies)/mL STANDARD_DEVIATION 0.6 • n=5 Participants	1.9 log10(copies)/mL STANDARD_DEVIATION 0.6 • n=4 Participants

PRIMARY outcome

Timeframe: up to 24 Weeks Post-Delivery for mother participants.

Population: All women randomized to vaccine or placebo, and who received the study treatment.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=115 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=115 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=116 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Women Who Experienced Various Adverse Events (AEs) Grade 3+ AEs, up to week 4, Step 1	2 Participants	3 Participants	4 Participants
Number of Women Who Experienced Various Adverse Events (AEs) Grade 4+ AEs, after week 4, Step 1	1 Participants	2 Participants	4 Participants
Number of Women Who Experienced Various Adverse Events (AEs) Grade 3+ AEs related to treatment, Step 1	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: up to 4 Weeks after Step 2 vaccination for Mother Participants

Population: Women who received Placebo in Step 1 and who were eligible and were randomized to Step 2.

The number of women who enrolled in Step 2, received vaccine and who experience grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 2 is presented.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=53 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=53 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Women Who Experienced Grade ≥ 3 Adverse Events (AEs) in Step 2 Grade 3+ AEs, up to week 4, Step 2	0 Participants	0 Participants	—
Number of Women Who Experienced Grade ≥ 3 Adverse Events (AEs) in Step 2 Grade 3+ AEs related to treatment, Step 2	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: through 24 weeks of life for infant participants

Population: Infants who were born on the study.

The number of infants who experience grade ≥ 3 adverse events (AEs), congenital defects, HIV infections or pneumonia, meningitis or IPD after maternal vaccination in Step 1, assessed from birth through 24 weeks of life for infant participants.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=112 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=116 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=119 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy Grade 3+ AEs,	23 Participants	23 Participants	24 Participants
Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy Congenital Anomalies	19 Participants	25 Participants	15 Participants
Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy HIV Infected	0 Participants	0 Participants	0 Participants
Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy Pneumonia, meningitis or IPD	5 Participants	8 Participants	8 Participants

PRIMARY outcome

Timeframe: 28 days after Immunization in Step 1

Population: Pregnant women who received the vaccination and did not deliver prior to the day 28 study visit and who had ELISA-measured IgG PNC antibody concentrations measured at baseline and at 28 days after immunization.

The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 to 1 or more serotypes. The proportion of participants with \>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at 28 days after immunization in Step 1 to 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=110 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=114 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=113 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Women With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations >=2 fold change from baseline to day 28	106 Participants	112 Participants	7 Participants
Number of Women With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations >=0.35ug.mL at day 28	109 Participants	114 Participants	106 Participants

PRIMARY outcome

Timeframe: 8 Weeks of Life

Population: The are the infants who were born on study and who had blood drawn for the week 8 evaluation prior to receiving their PCV-10 vaccination.

The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 8 weeks of age to 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=105 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=108 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=109 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 8 Weeks of Age	87 Participants	95 Participants	46 Participants

SECONDARY outcome

Timeframe: At Delivery for Mother Participants and Birth for Infant Participants

Population: These are the mother-infant pairs who meet the criteria of receipt of study product for the moms and have data for delivery/birth time point.

The ratios of infant/mother PNC antibody levels to study used serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=109 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=113 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=115 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Ratio of Infant/Mother PNC Antibody Levels	0.92 ratio Interval 0.91 to 0.93	0.93 ratio Interval 0.92 to 0.94	0.90 ratio Interval 0.89 to 0.91

SECONDARY outcome

Timeframe: at Labor and Delivery and 24 Weeks Post-Delivery for Mother Participants

The number of participants with a \>=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at the time points listed for 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=113 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=115 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=116 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Participants With a >=0.35ug/mL ELISA-measured IgG PNC Antibody Concentrations at Labor/Delivery and 24 Weeks Post-partum at labor and delivery	109 Participants	115 Participants	16 Participants
Number of Participants With a >=0.35ug/mL ELISA-measured IgG PNC Antibody Concentrations at Labor/Delivery and 24 Weeks Post-partum at 24 weeks post partum	105 Participants	107 Participants	58 Participants

SECONDARY outcome

Timeframe: 28 days after Immunization in Step 1 and in Step 2

Population: Women who received PPV-23 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.

The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=110 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=51 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PPV-23 Vaccination in Step 1 and Step 2	106 Participants	49 Participants	—

SECONDARY outcome

Timeframe: 28 days after Immunization in Step 1 and in Step 2

Population: Women who received PCV-10 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.

The proportion of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=114 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=48 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PCV-10 Vaccination in Step 1 and Step 2	112 Participants	48 Participants	—

SECONDARY outcome

Timeframe: at weeks 16 and 24 of life

Population: These are the infants who were born on study and received the PCV-10 vaccination in the windows allowed by the protocol (prior to week 8 and prior to week 16). The number of infants with nonmissing data who received the vaccination as required are indicated.

The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 16 and 24 weeks of age to 1 or more serotypes.

Outcome measures

Outcome measures
Measure	Arm 1A (PPV-23) n=102 Participants In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=99 Participants In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=99 Participants In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 16 and 24 Weeks of Age at week 16	100 Participants	94 Participants	95 Participants
Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 16 and 24 Weeks of Age at week 24	102 Participants	98 Participants	97 Participants

Adverse Events

Arm 1A (PPV-23)

Serious events: 15 serious events

Other events: 66 other events

Deaths: 0 deaths

Arm 1B (PCV-10)

Serious events: 15 serious events

Other events: 63 other events

Deaths: 0 deaths

Arm 1C (Placebo)

Serious events: 16 serious events

Other events: 62 other events

Deaths: 1 deaths

Arm 2A (PPV-23)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2B (PCV-10)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Infants of Mothers in Arm 1A (PPV-23)

Serious events: 20 serious events

Other events: 9 other events

Deaths: 1 deaths

Infants of Mothers in Arm 1B (PCV-10)

Serious events: 21 serious events

Other events: 8 other events

Deaths: 1 deaths

Infants of Mothers in Arm 1C (Placebo)

Serious events: 19 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1A (PPV-23) n=115 participants at risk In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=115 participants at risk In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=116 participants at risk In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.	Arm 2A (PPV-23) n=53 participants at risk In Step 2, women in Arm 2A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 2B (PCV-10) n=53 participants at risk In Step 2, women in Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Infants of Mothers in Arm 1A (PPV-23) n=115 participants at risk；n=114 participants at risk These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Infants of Mothers in Arm 1B (PCV-10) n=117 participants at risk；n=116 participants at risk These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Infants of Mothers in Arm 1C (Placebo) n=119 participants at risk These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Blood and lymphatic system disorders Anaemia	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Gastrointestinal disorders Abdominal pain	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Gastrointestinal disorders Pancreatic mass	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Immune system disorders Hypersensitivity	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Cellulitis	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Endometritis	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Postoperative wound infection	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Pyelonephritis	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Sepsis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Pulmonary sepsis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Bacterial sepsis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Pneumonia bacterial	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Uterine infection	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Incision site infection	2.6% 3/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Nervous system disorders Headache	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Foetal distress syndrom	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Oligohydramnios	1.7% 2/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	5.2% 6/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Premature labour	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	2.6% 3/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Threatened labour	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Preterm premature rupture	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Vascular disorders Hypertension	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Cardiac disorders Pulmonary valve stenosis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Congenital, familial and genetic disorders Congenital diaphragmatic hernia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Congenital, familial and genetic disorders Congenital hydrocephalus	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.1% 7/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	3.4% 4/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Gastrointestinal disorders Diarrhoea	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
General disorders Fever neonatal	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Hepatobiliary disorders Jaundice	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.87% 1/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Bronchiolitis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	5.3% 6/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.2% 5/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Gastroenteritis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Neurosyphilis	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Pneumonia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.8% 2/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Sepsis neonatal	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	2.6% 3/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Urinary tract infection	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Nervous system disorders Seizure	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of newborn	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.7% 2/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Neonatal hypoxia	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.88% 1/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/114 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.84% 1/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).

Other adverse events

Other adverse events
Measure	Arm 1A (PPV-23) n=115 participants at risk In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 1B (PCV-10) n=115 participants at risk In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Arm 1C (Placebo) n=116 participants at risk In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.	Arm 2A (PPV-23) n=53 participants at risk In Step 2, women in Arm 2A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Arm 2B (PCV-10) n=53 participants at risk In Step 2, women in Arm 2B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Infants of Mothers in Arm 1A (PPV-23) n=115 participants at risk；n=114 participants at risk These are the infants born to women enrolled in Arm 1A. In Step 1, women in Arm 1A were administered a 0.5 milliliter (mL) dose of PPV-23 intramuscularly once. PPV-23: PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.	Infants of Mothers in Arm 1B (PCV-10) n=117 participants at risk；n=116 participants at risk These are the infants born to women enrolled in Arm 1B. In Step 1, women in Arm 1B were administered a 0.5 mL dose of PCV-10 intramuscularly once. PCV-10: PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.	Infants of Mothers in Arm 1C (Placebo) n=119 participants at risk These are the infants born to women enrolled in Arm 1C. In Step 1, women in Arm 1C were administered a 0.5 mL dose of 0.9 percent Sodium Chloride (NaCl) intramuscularly once. NaCl: NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
Gastrointestinal disorders Abdominal pain	12.2% 14/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	15.7% 18/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.9% 1/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Gastrointestinal disorders Vomiting	4.3% 5/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	8.7% 10/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.9% 1/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
General disorders Injection site pain	2.6% 3/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	11.3% 13/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.86% 1/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	5.7% 3/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	5.7% 3/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
General disorders Pyrexia	7.0% 8/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	7.8% 9/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.9% 1/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	3.8% 2/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	4.3% 5/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.7% 8/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Urinary tract infection	2.6% 3/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.9% 8/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Infections and infestations Vulvovaginal candidiasis	4.3% 5/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.1% 7/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	10.3% 12/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Investigations Blood pressure increased	5.2% 6/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	7.0% 8/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.0% 7/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.9% 1/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Investigations Haemoglobin decreased	33.0% 38/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	27.8% 32/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	25.0% 29/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Nervous system disorders Headache	15.7% 18/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	9.6% 11/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	15.5% 18/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	1.9% 1/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	3.8% 2/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Reproductive system and breast disorders Vaginal discharge	7.0% 8/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	7.8% 9/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	8.6% 10/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	6.1% 7/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	2.6% 3/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	3.4% 4/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/116 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.00% 0/53 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	5.2% 6/115 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	0.85% 1/117 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).	7.6% 9/119 • For women: up to 28 weeks post-delivery (24 weeks +4 week window) for Steps 1A, 1B, 1C or those who continued to Step 3 (no additional safety follow-up was performed in Step 3); 4 weeks for Steps 2A and 2B; and up to 28 weeks for infants (24 weeks +4 week window). For women: all grade \>=2 signs/symptoms and diagnoses, and all hematology (CBC with differential and platelet count) adverse events. AEs collected for infants: infant death, congenital anomalies, prematurity, low birth weight, neonatal infections/sepsis, Neonatal Intensive Care Unit (NICU) admission, HIV transmission to infant, functional defects (hearing impairment, growth impairment, developmental delay) and Grade ≥ 3 AEs. SAEs were reported according to DAIDS EAE Manual V2.0 (see References).

Additional Information

Lauren Laimon, Senior Study Director

Westat

Phone: 240-453-2987

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place