Trial Outcomes & Findings for Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants (NCT NCT03048422)

NCT ID: NCT03048422

Last Updated: 2022-11-21

Results Overview

Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 643 participants
• Primary outcome timeframe: Delivery
• Results posted on: 2022-11-21

Participant Flow

Participant milestones

Measure	Arm 1: Maternal DTG+FTC/TAF Mothers randomized to receive DTG+FTC/TAF	Arm 2: Maternal DTG+FTC/TDF Mothers randomized to receive DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Overall Study STARTED	217	215	211
Overall Study COMPLETED	200	205	202
Overall Study NOT COMPLETED	17	10	9

Reasons for withdrawal

Measure	Arm 1: Maternal DTG+FTC/TAF Mothers randomized to receive DTG+FTC/TAF	Arm 2: Maternal DTG+FTC/TDF Mothers randomized to receive DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Overall Study Death	1	0	0
Overall Study Lost to Follow-up	5	0	1
Overall Study Withdrawal by Subject	5	7	4
Overall Study Moved	3	2	2
Overall Study Noncompliant with Study Requirements	2	1	2
Overall Study Not Able to Get to Clinic	1	0	0

Baseline Characteristics

Plasma HIV RNA viral load among participants who had baseline viral load data available.

Baseline characteristics by cohort

Measure	Arm 1: Maternal DTG+FTC/TAF n=217 Participants Mothers randomized to receive DTG+FTC/TAF	Arm 2: Maternal DTG+FTC/TDF n=215 Participants Mothers randomized to receive DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF	Total n=643 Participants Total of all reporting groups
Age, Continuous	27.5 years STANDARD_DEVIATION 6.2 • n=217 Participants	27.0 years STANDARD_DEVIATION 5.8 • n=215 Participants	27.7 years STANDARD_DEVIATION 5.9 • n=211 Participants	27.4 years STANDARD_DEVIATION 6.0 • n=643 Participants
Sex: Female, Male Female	217 Participants n=217 Participants	215 Participants n=215 Participants	211 Participants n=211 Participants	643 Participants n=643 Participants
Sex: Female, Male Male	0 Participants n=217 Participants	0 Participants n=215 Participants	0 Participants n=211 Participants	0 Participants n=643 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=217 Participants	21 Participants n=215 Participants	18 Participants n=211 Participants	60 Participants n=643 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=217 Participants	192 Participants n=215 Participants	190 Participants n=211 Participants	576 Participants n=643 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=217 Participants	2 Participants n=215 Participants	3 Participants n=211 Participants	7 Participants n=643 Participants
Race/Ethnicity, Customized Race · Black or African American	195 Participants n=217 Participants	196 Participants n=215 Participants	194 Participants n=211 Participants	585 Participants n=643 Participants
Race/Ethnicity, Customized Race · Asian	7 Participants n=217 Participants	5 Participants n=215 Participants	6 Participants n=211 Participants	18 Participants n=643 Participants
Race/Ethnicity, Customized Race · Other	10 Participants n=217 Participants	6 Participants n=215 Participants	4 Participants n=211 Participants	20 Participants n=643 Participants
Race/Ethnicity, Customized Race · White	5 Participants n=217 Participants	7 Participants n=215 Participants	7 Participants n=211 Participants	19 Participants n=643 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=217 Participants	1 Participants n=215 Participants	0 Participants n=211 Participants	1 Participants n=643 Participants
Region of Enrollment United States	2 Participants n=217 Participants	2 Participants n=215 Participants	0 Participants n=211 Participants	4 Participants n=643 Participants
Region of Enrollment Botswana	16 Participants n=217 Participants	18 Participants n=215 Participants	17 Participants n=211 Participants	51 Participants n=643 Participants
Region of Enrollment Tanzania	15 Participants n=217 Participants	13 Participants n=215 Participants	15 Participants n=211 Participants	43 Participants n=643 Participants
Region of Enrollment Brazil	21 Participants n=217 Participants	19 Participants n=215 Participants	17 Participants n=211 Participants	57 Participants n=643 Participants
Region of Enrollment South Africa	37 Participants n=217 Participants	37 Participants n=215 Participants	37 Participants n=211 Participants	111 Participants n=643 Participants
Region of Enrollment Uganda	37 Participants n=217 Participants	37 Participants n=215 Participants	36 Participants n=211 Participants	110 Participants n=643 Participants
Region of Enrollment Zimbabwe	82 Participants n=217 Participants	84 Participants n=215 Participants	83 Participants n=211 Participants	249 Participants n=643 Participants
Region of Enrollment Thailand	5 Participants n=217 Participants	4 Participants n=215 Participants	6 Participants n=211 Participants	15 Participants n=643 Participants
Region of Enrollment India	2 Participants n=217 Participants	1 Participants n=215 Participants	0 Participants n=211 Participants	3 Participants n=643 Participants
Gestational Age	21.6 weeks STANDARD_DEVIATION 4.2 • n=217 Participants	21.4 weeks STANDARD_DEVIATION 4.2 • n=215 Participants	21.8 weeks STANDARD_DEVIATION 4.2 • n=211 Participants	21.6 weeks STANDARD_DEVIATION 4.2 • n=643 Participants
Gestational Age Stratification Group 14-18 Weeks	58 Participants n=217 Participants	64 Participants n=215 Participants	59 Participants n=211 Participants	181 Participants n=643 Participants
Gestational Age Stratification Group 19-23 Weeks	93 Participants n=217 Participants	83 Participants n=215 Participants	77 Participants n=211 Participants	253 Participants n=643 Participants
Gestational Age Stratification Group 24-28 Weeks	66 Participants n=217 Participants	68 Participants n=215 Participants	75 Participants n=211 Participants	209 Participants n=643 Participants
Plasma HIV-1 RNA Viral Load	14,558.2 copies/mL STANDARD_DEVIATION 45,813.9 • n=216 Participants • Plasma HIV RNA viral load among participants who had baseline viral load data available.	18,420.3 copies/mL STANDARD_DEVIATION 97,896.4 • n=215 Participants • Plasma HIV RNA viral load among participants who had baseline viral load data available.	13,381.2 copies/mL STANDARD_DEVIATION 42,042.5 • n=209 Participants • Plasma HIV RNA viral load among participants who had baseline viral load data available.	15,471.2 copies/mL STANDARD_DEVIATION 67,050.5 • n=640 Participants • Plasma HIV RNA viral load among participants who had baseline viral load data available.
Plasma HIV-1 RNA Viral Load <200 copies/mL	62 Participants n=216 Participants • Participants with plasma HIV-1 RNA viral load data available at baseline	66 Participants n=215 Participants • Participants with plasma HIV-1 RNA viral load data available at baseline	53 Participants n=209 Participants • Participants with plasma HIV-1 RNA viral load data available at baseline	181 Participants n=640 Participants • Participants with plasma HIV-1 RNA viral load data available at baseline
Weight	67.7 kg STANDARD_DEVIATION 15.1 • n=217 Participants	66.3 kg STANDARD_DEVIATION 16.8 • n=215 Participants	64.5 kg STANDARD_DEVIATION 13.3 • n=211 Participants	66.2 kg STANDARD_DEVIATION 15.2 • n=643 Participants

PRIMARY outcome

Timeframe: Delivery

Population: Women who had plasma HIV-1 RNA viral load data available at delivery

Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=405 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=200 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery Intention-to-Treat Analysis	97.5 Percentage of participants	91.0 Percentage of participants	—
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery Per-Protocol Analysis	97.5 Percentage of participants	91.4 Percentage of participants	—

PRIMARY outcome

Timeframe: Delivery

Population: Mother-infant pairs with pregnancy outcome evaluated on study.

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards)

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=216 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=213 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome	24.1 percentage of mother-infant pairs	32.9 percentage of mother-infant pairs	32.7 percentage of mother-infant pairs

PRIMARY outcome

Timeframe: From randomization up to 74 weeks

Population: Enrolled women.

The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.

Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event	25.1 Cumulative probability per 100 persons	30.8 Cumulative probability per 100 persons	27.9 Cumulative probability per 100 persons

PRIMARY outcome

Timeframe: From birth through Week 50 postpartum

Population: Live born infants

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=208 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=202 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event	25.3 Cumulative probability per 100 persons	28.6 Cumulative probability per 100 persons	30.9 Cumulative probability per 100 persons

SECONDARY outcome

Timeframe: Delivery

Population: Women with viral load data available from central laboratory

Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=377 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=184 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory	94.4 percentage of participants	78.8 percentage of participants	—

SECONDARY outcome

Timeframe: 50 weeks postpartum

Population: Women with viral load data available.

Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=380 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=193 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum	96.3 percentage of participants	96.4 percentage of participants	—

SECONDARY outcome

Timeframe: Randomization to delivery

Population: Women with viral load data available.

Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=430 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=210 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery	4.26 weeks Standard Error 0.09	6.49 weeks Standard Error 0.31	—

SECONDARY outcome

Timeframe: Delivery

Population: Enrolled women

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm	88.9 percentage of participants	92.6 percentage of participants	81.0 percentage of participants

SECONDARY outcome

Timeframe: 50 weeks postpartum

Population: Enrolled women

Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm	75.6 percentage of participants	77.7 percentage of participants	76.3 percentage of participants

SECONDARY outcome

Timeframe: Delivery

Population: Mother-infant pairs with pregnancy outcome evaluated on study

Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards)

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=429 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome	28.4 percentage of mother-infant pairs	32.7 percentage of mother-infant pairs	—

SECONDARY outcome

Timeframe: From randomization up to 74 weeks

Population: Enrolled women.

The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.

Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=432 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event	27.9 Cumulative probability per 100 persons	27.9 Cumulative probability per 100 persons	—

SECONDARY outcome

Timeframe: Birth through Week 50 postpartum

Population: Live born infants

The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=410 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event	26.8 Cumulative probability per 100 persons	30.9 Cumulative probability per 100 persons	—

SECONDARY outcome

Timeframe: Delivery through 50 weeks postpartum

Population: Mother-infant pairs with pregnancy outcome evaluated on study.

Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=216 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=213 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly	24.1 percentage of mother-infant pairs	32.9 percentage of mother-infant pairs	33.2 percentage of mother-infant pairs

SECONDARY outcome

Timeframe: Birth through 50 weeks postpartum

Population: Mother-infant pairs with pregnancy outcome evaluated on study.

Infant and pregnancy outcomes were classified on a scale of 1 to 10, with mother-infant pairs categorized by the worst outcome they experienced (worst category being 1 and best being 10): 1) Infant death; 2) Spontaneous abortion (<20 weeks gestation) or stillbirth (≥20 weeks gestation); 3) Infant HIV infection; 4) Extremely and very early preterm (<32 completed weeks); 5) Major congenital anomaly; 6) Preterm delivery (<37 completed weeks); 7) Small for gestational age (<10th percentile); 8) Infant hospitalization; 9) Infant grade 3 or 4 adverse event; 10) None of the above. If a mother-infant pair experienced more than one safety outcome, only the worst was reported.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=216 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=213 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Infant Death	2 Participants	4 Participants	14 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Spontaneous abortion or stillbirth	8 Participants	11 Participants	4 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome HIV-1 Infection	2 Participants	0 Participants	1 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Extremely and Very Preterm Delivery	1 Participants	1 Participants	2 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Major Congenital Anomaly	2 Participants	0 Participants	1 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Preterm Delivery	10 Participants	17 Participants	18 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Small for Gestational Age	29 Participants	38 Participants	36 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Infant Hospitalization	18 Participants	14 Participants	19 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome Infant Grade 3 or 4 Adverse Event	7 Participants	8 Participants	6 Participants
Count of Mother-infant Pairs in the Classified Ranked Composite Safety Outcome None	137 Participants	120 Participants	110 Participants

SECONDARY outcome

Timeframe: Birth through 50 weeks after birth

Population: Live born infants

The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=208 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=202 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Infant HIV-infection	0.98 Cumulative probability per 100 persons	0.50 Cumulative probability per 100 persons	0.55 Cumulative probability per 100 persons

SECONDARY outcome

Timeframe: Birth through 50 weeks after birth

Population: Live born infants

The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=208 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=202 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF
Cumulative Probability of Infant Deaths	1.0 Cumulative probability per 100 persons	2.0 Cumulative probability per 100 persons	6.9 Cumulative probability per 100 persons

SECONDARY outcome

Timeframe: Baseline to 50 weeks postpartum

Population: Women with creatinine clearance data.

Maternal change in creatinine clearance per week based on generalized estimating equations

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=215 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=214 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=210 Participants Mothers randomized to receive EFV/FTC/TDF
Maternal Change in Creatinine Clearance	-0.980 mL/min Interval -1.066 to -0.894	-0.887 mL/min Interval -0.964 to -0.81	-0.935 mL/min Interval -1.013 to -0.857

SECONDARY outcome

Timeframe: Delivery and 26 weeks postpartum

Population: Live born infants with creatinine clearance data

Infant creatinine clearance based on Schwartz formula

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=193 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=189 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=185 Participants Mothers randomized to receive EFV/FTC/TDF
Infant Creatinine Clearance Delivery	52.7 mL/min Standard Deviation 29.6	53.1 mL/min Standard Deviation 69.7	49.0 mL/min Standard Deviation 24.7
Infant Creatinine Clearance 26 Weeks Postpartum	134.8 mL/min Standard Deviation 109.6	123.6 mL/min Standard Deviation 40.3	135.0 mL/min Standard Deviation 51.1

SECONDARY outcome

Timeframe: From 24 weeks after randomization through Week 50 postpartum

Population: All enrolled women

Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure	0.92 percentage of participants	1.86 percentage of participants	6.16 percentage of participants

SECONDARY outcome

Timeframe: From birth through 50 weeks postpartum

Population: Infants who had an HIV diagnosis.

Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results.

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=2 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=1 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=1 Participants Mothers randomized to receive EFV/FTC/TDF
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Delivery

Population: Women with pregnancies resulting in a live born infant

Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=208 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=202 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Mother-Infant Pairs With Preterm Deliveries	5.8 percentage of participants	9.4 percentage of participants	12.1 percentage of participants

SECONDARY outcome

Timeframe: Birth

Population: Live born infants with weight and sex data available.

Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=202 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=200 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=200 Participants Mothers randomized to receive EFV/FTC/TDF
Percentage of Infants Born Small for Gestational Age	16.3 percentage of participants	22.5 percentage of participants	20.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline through before delivery (up to one day prior)

Population: Women with weight data available.

Change in maternal antepartum weight per week based on generalized estimating equations

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=210 Participants Mothers randomized to receive EFV/FTC/TDF
Change in Maternal Weight Antepartum	0.378 kg/week Interval 0.343 to 0.412	0.319 kg/week Interval 0.291 to 0.348	0.291 kg/week Interval 0.26 to 0.322

SECONDARY outcome

Timeframe: Delivery to 50 weeks postpartum

Population: Women with weight data available.

Change in maternal postpartum weight per week based on generalized estimating equations

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=212 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=212 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=207 Participants Mothers randomized to receive EFV/FTC/TDF
Change in Maternal Weight Postpartum	0.014 kg/week Interval -0.004 to 0.032	-0.008 kg/week Interval -0.027 to 0.012	-0.032 kg/week Interval -0.048 to -0.017

SECONDARY outcome

Timeframe: Baseline to 50 weeks postpartum

Population: Women with weight data available.

Change in maternal weight per week based on generalized estimating equations

Outcome measures

Measure	Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF n=217 Participants Combined group of mothers randomized to receive dolutegravir DTG+FTC/TAF or DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=215 Participants Mothers randomized to receive EFV/FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 Participants Mothers randomized to receive EFV/FTC/TDF
Change in Maternal Weight Overall	-0.027 kg/week Interval -0.042 to -0.012	-0.050 kg/week Interval -0.066 to -0.034	-0.084 kg/week Interval -0.098 to -0.07

Adverse Events

Arm 1: Maternal DTG+FTC/TAF

Serious events: 39 serious events

Other events: 189 other events

Deaths: 1 deaths

Arm 2: Maternal DTG+FTC/TDF

Serious events: 39 serious events

Other events: 198 other events

Deaths: 0 deaths

Arm 3: Maternal EFV/FTC/TDF

Serious events: 40 serious events

Other events: 143 other events

Deaths: 0 deaths

Arm 1 Infants

Serious events: 35 serious events

Other events: 34 other events

Deaths: 2 deaths

Arm 2 Infants

Serious events: 29 serious events

Other events: 40 other events

Deaths: 4 deaths

Arm 3 Infants

Serious events: 44 serious events

Other events: 34 other events

Deaths: 14 deaths

Serious adverse events

Measure	Arm 1: Maternal DTG+FTC/TAF n=217 participants at risk Mothers randomized to receive DTG+FTC/TAF	Arm 2: Maternal DTG+FTC/TDF n=215 participants at risk Mothers randomized to receive DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 participants at risk Mothers randomized to receive EFV/FTC/TDF	Arm 1 Infants n=208 participants at risk Infants born to women who were randomized to receive DTG+FTC/TAF during pregnancy and postpartum	Arm 2 Infants n=202 participants at risk Infants born to women who were randomized to receive DTG+FTC/TDF during pregnancy and postpartum	Arm 3 Infants n=207 participants at risk Infants born to women who were randomized to receive EFV/FTC/TDF during pregnancy and postpartum
Infections and infestations Postoperative wound infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia of pregnancy	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Neutropenia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Thrombocytopenia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Cardiac disorders Cardiac failure	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Cardiac disorders Pericardial effusion	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Accessory auricle	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Anomalous pulmonary venous connection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Arachnodactyly	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital foot malformation	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital inguinal hernia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital joint malformation	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital mitral valve incompetence	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital skin dimples	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital tricuspid valve incompetence	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital ureteric anomaly	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Duodenal atresia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Haemangioma congenital	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Macrocephaly	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Multiple congenital abnormalities	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Naevus flammeus	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Patent ductus arteriosus	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Sickle cell anaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Sickle cell disease	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Talipes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Gastrointestinal disorders Diarrhoea	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Gastrointestinal disorders Ileal stenosis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Gastrointestinal disorders Ileus paralytic	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Gastrointestinal disorders Infantile vomiting	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
General disorders Death neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
General disorders Fever neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
General disorders Pyrexia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Abscess limb	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Amniotic cavity infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Bacteraemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Bacterial sepsis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Bronchiolitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Bronchitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Cellulitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Conjunctivitis bacterial	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Dengue fever	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Disseminated tuberculosis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Gastroenteritis	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.97% 2/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Malaria	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Meningitis pneumococcal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Neonatal pneumonia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pelvic inflammatory disease	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Peritonitis	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pneumonia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.99% 2/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.4% 5/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pneumonia bacterial	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Postpartum sepsis	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pyelonephritis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pyometra	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Sepsis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Sepsis neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.5% 7/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.9% 6/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Septic shock	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Staphylococcal scalded skin syndrome	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.97% 2/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Tracheobronchitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Upper respiratory tract infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Urinary tract infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Urinary tract infection neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Wound sepsis	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Injury, poisoning and procedural complications Uterine rupture	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Alanine aminotransferase increased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood bilirubin increased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood glucose decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood potassium increased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Cardiac murmur	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Haemoglobin decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Dehydration	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Fontanelle bulging	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Hydrocephalus	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.4% 5/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Infant irritability	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Muscle contractions involuntary	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Neonatal seizure	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Presyncope	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Status epilepticus	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Birth trauma	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Cervix dystocia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Eclampsia	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Failed induction of labour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Failed trial of labour	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions False labour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Foetal death	2.8% 6/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.3% 7/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.4% 5/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	1.8% 4/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.3% 5/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.3% 7/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Hydrops foetalis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Hypothermia neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Imminent abortion	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Large for dates baby	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Neonatal disorder	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	1.8% 4/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.5% 5/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature delivery	1.8% 4/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	1.4% 3/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Threatened labour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Umbilical cord around neck	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Umbilical cord cyst	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Umbilical cord prolapse	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Uterine atony	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Alcoholism	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Renal and urinary disorders Acute kidney injury	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Grunting	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.4% 5/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.97% 2/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.99% 2/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.4% 5/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.99% 2/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.97% 2/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal tachypnoea	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Use of accessory respiratory muscles	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Rash neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Social circumstances Physical assault	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Vascular disorders Deep vein thrombosis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Vascular disorders Essential hypertension	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.

Other adverse events

Measure	Arm 1: Maternal DTG+FTC/TAF n=217 participants at risk Mothers randomized to receive DTG+FTC/TAF	Arm 2: Maternal DTG+FTC/TDF n=215 participants at risk Mothers randomized to receive DTG+FTC/TDF	Arm 3: Maternal EFV/FTC/TDF n=211 participants at risk Mothers randomized to receive EFV/FTC/TDF	Arm 1 Infants n=208 participants at risk Infants born to women who were randomized to receive DTG+FTC/TAF during pregnancy and postpartum	Arm 2 Infants n=202 participants at risk Infants born to women who were randomized to receive DTG+FTC/TDF during pregnancy and postpartum	Arm 3 Infants n=207 participants at risk Infants born to women who were randomized to receive EFV/FTC/TDF during pregnancy and postpartum
General disorders Developmental delay	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Anaemia of pregnancy	1.4% 3/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Neutropenia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital joint malformation	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital toxoplasmosis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Polydactyly	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.97% 2/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
General disorders Macrosomia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
General disorders Pyrexia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Immune system disorders Hypersensitivity	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Acarodermatitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Amniotic cavity infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Bronchiolitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations COVID-19	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Conjunctivitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Diarrhoea infectious	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Furuncle	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Gastroenteritis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Genital herpes simplex	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Herpes simplex	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Impetigo	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Lower respiratory tract infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Perihepatitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pneumonia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Pneumonia bacterial	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Postoperative wound infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Postpartum sepsis	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Sepsis neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Skin bacterial infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Tracheobronchitis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Tuberculous pleurisy	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Upper respiratory tract infection	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Urinary tract infection	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Infections and infestations Vulvovaginitis trichomonal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Injury, poisoning and procedural complications Lower limb fracture	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Alanine aminotransferase increased	2.3% 5/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	2.8% 6/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Amylase increased	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Aspartate aminotransferase increased	1.4% 3/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Bilirubin conjugated increased	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood alkaline phosphatase increased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood creatinine increased	78.3% 170/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	83.3% 179/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	36.0% 76/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	4.0% 8/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood glucose decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.99% 2/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.9% 4/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood pressure increased	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Blood sodium decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Creatinine renal clearance decreased	83.9% 182/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	89.8% 193/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	62.6% 132/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Haemoglobin decreased	3.7% 8/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	9.3% 20/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	6.6% 14/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.8% 8/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	4.0% 8/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.4% 7/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Head lag	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Hepatic enzyme increased	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Neutrophil count decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	4.8% 10/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	3.5% 7/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	6.8% 14/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Neutrophil count increased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Platelet count decreased	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.5% 3/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations Weight decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Investigations White blood cell count decreased	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Malnutrition	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Poor feeding infant	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Metabolism and nutrition disorders Underweight	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Neonatal seizure	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Poor sucking reflex	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Nervous system disorders Somnolence	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.96% 2/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Morning sickness	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.93% 2/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature delivery	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature labour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Abnormal behaviour	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Anxiety	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Depression	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Hallucination, visual	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Insomnia	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Irritability	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Major depression	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Perinatal depression	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Psychiatric disorders Suicidal ideation	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Renal and urinary disorders Acute kidney injury	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Reproductive system and breast disorders Vaginal haemorrhage	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Neonatal tachypnoea	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.50% 1/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Rash	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	1.4% 3/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.48% 1/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Urticaria	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Skin and subcutaneous tissue disorders Urticaria papular	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Surgical and medical procedures Abortion induced	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Surgical and medical procedures Caesarean section	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Vascular disorders Hypertension	0.92% 2/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.95% 2/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Vascular disorders Hypotension	0.46% 1/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.
Vascular disorders Varicose vein	0.00% 0/217 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.47% 1/215 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/211 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/208 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/202 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.	0.00% 0/207 • For women, adverse events were reported from randomization through study visit occurring at 50 weeks postpartum. For infants, adverse events were reported from birth through the study visit occurring at 50 weeks post birth. All grade 3 or higher and serious adverse events were reported. Other targeted lower grade adverse events. All randomized women and live born infants were summarized. The DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017, was used in this study. A full description of adverse event data collection is provided in protocol Section 7.2.

Additional Information

IMPAACT Clinicaltrials.gov Coordinator

Family Health International (FHI 360)

Phone: (919) 405-1429

Email: IMPAACT.ctgov@fstrf.org

Results disclosure agreements

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