Trial Outcomes & Findings for Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries (NCT NCT01061151)

NCT ID: NCT01061151

Last Updated: 2022-02-11

Results Overview

Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3747 participants
• Primary outcome timeframe: Measured at birth or Week 1 study visit
• Results posted on: 2022-02-11

Participant Flow

From April 2011 to October 2014, pregnant or just-delivered women were recruited at medical centers in low-income countries.

Participant milestones

Measure	Antepartum Arm A Mothers received ZDV+sdNVP+TRV tail	Antepartum Arm B Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Late Presenters Registrational component to assess entry criteria for possible randomization in the Postpartum Component
Protocol Version 2.0: 04/2011-09/2012 STARTED	855	861	25	129
Protocol Version 2.0: 04/2011-09/2012 Mothers That Met All Inclusion Criteria	853	861	24	129
Protocol Version 2.0: 04/2011-09/2012 COMPLETED	623	620	16	101
Protocol Version 2.0: 04/2011-09/2012 NOT COMPLETED	232	241	9	28
Protocol Version 3.0: 10/2012-10/2014 STARTED	694	686	422	75
Protocol Version 3.0: 10/2012-10/2014 Mothers That Met All Inclusion Criteria	694	684	421	75
Protocol Version 3.0: 10/2012-10/2014 COMPLETED	542	548	345	55
Protocol Version 3.0: 10/2012-10/2014 NOT COMPLETED	152	138	77	20

Reasons for withdrawal

Measure	Antepartum Arm A Mothers received ZDV+sdNVP+TRV tail	Antepartum Arm B Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Late Presenters Registrational component to assess entry criteria for possible randomization in the Postpartum Component
Protocol Version 2.0: 04/2011-09/2012 Protocol Violation	2	0	0	1
Protocol Version 2.0: 04/2011-09/2012 Death	6	9	1	2
Protocol Version 2.0: 04/2011-09/2012 Withdrawal by Subject	89	82	2	10
Protocol Version 2.0: 04/2011-09/2012 Lost to Follow-up	73	65	2	10
Protocol Version 2.0: 04/2011-09/2012 Site Closure	15	19	1	0
Protocol Version 2.0: 04/2011-09/2012 Subject Unable to Get to Clinic	44	61	2	5
Protocol Version 2.0: 04/2011-09/2012 Other Reason	3	5	1	0
Protocol Version 3.0: 10/2012-10/2014 Protocol Violation	0	0	2	4
Protocol Version 3.0: 10/2012-10/2014 Adverse Event	1	0	0	0
Protocol Version 3.0: 10/2012-10/2014 Death	3	5	1	1
Protocol Version 3.0: 10/2012-10/2014 Withdrawal by Subject	54	52	31	3
Protocol Version 3.0: 10/2012-10/2014 Lost to Follow-up	49	36	25	4
Protocol Version 3.0: 10/2012-10/2014 Site Closure	12	11	2	0
Protocol Version 3.0: 10/2012-10/2014 Subject Unable to Get to Clinic	28	26	15	5
Protocol Version 3.0: 10/2012-10/2014 Other Reason	5	8	1	3

Baseline Characteristics

Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine

Baseline characteristics by cohort

Measure	Antepartum Arm A n=1547 Participants Mothers received ZDV+sdNVP+TRV tail	Antepartum Arm B n=1545 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=445 Participants Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Late Presenters n=204 Participants Registrational component to assess entry criteria for possible randomization in the Postpartum Component	Total n=3741 Participants Total of all reporting groups
The Last ARV Regimen before Entry during the Current Pregnancy One NRTI	326 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	336 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	125 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	0 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	787 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine
Age, Continuous	26.5 years n=1547 Participants	26.6 years n=1545 Participants	26.4 years n=445 Participants	26.8 years n=204 Participants	26.5 years n=3741 Participants
Sex: Female, Male Female	1547 Participants n=1547 Participants	1545 Participants n=1545 Participants	445 Participants n=445 Participants	204 Participants n=204 Participants	3741 Participants n=3741 Participants
Sex: Female, Male Male	0 Participants n=1547 Participants	0 Participants n=1545 Participants	0 Participants n=445 Participants	0 Participants n=204 Participants	0 Participants n=3741 Participants
Race/Ethnicity, Customized Black Non-Hispanic	1493 Participants n=1547 Participants	1487 Participants n=1545 Participants	440 Participants n=445 Participants	183 Participants n=204 Participants	3603 Participants n=3741 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	7 Participants n=1547 Participants	12 Participants n=1545 Participants	4 Participants n=445 Participants	2 Participants n=204 Participants	25 Participants n=3741 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	47 Participants n=1547 Participants	46 Participants n=1545 Participants	1 Participants n=445 Participants	19 Participants n=204 Participants	113 Participants n=3741 Participants
Region of Enrollment Malawi	489 Participants n=1547 Participants	493 Participants n=1545 Participants	155 Participants n=445 Participants	31 Participants n=204 Participants	1168 Participants n=3741 Participants
Region of Enrollment Tanzania	23 Participants n=1547 Participants	24 Participants n=1545 Participants	10 Participants n=445 Participants	0 Participants n=204 Participants	57 Participants n=3741 Participants
Region of Enrollment South Africa	513 Participants n=1547 Participants	510 Participants n=1545 Participants	78 Participants n=445 Participants	27 Participants n=204 Participants	1128 Participants n=3741 Participants
Region of Enrollment Uganda	207 Participants n=1547 Participants	205 Participants n=1545 Participants	85 Participants n=445 Participants	9 Participants n=204 Participants	506 Participants n=3741 Participants
Region of Enrollment Zimbabwe	237 Participants n=1547 Participants	236 Participants n=1545 Participants	99 Participants n=445 Participants	116 Participants n=204 Participants	688 Participants n=3741 Participants
Region of Enrollment Zambia	32 Participants n=1547 Participants	31 Participants n=1545 Participants	18 Participants n=445 Participants	2 Participants n=204 Participants	83 Participants n=3741 Participants
Region of Enrollment India	46 Participants n=1547 Participants	46 Participants n=1545 Participants	0 Participants n=445 Participants	19 Participants n=204 Participants	111 Participants n=3741 Participants
Weight	64 kg n=1547 Participants • Some late presenters had incomplete measurements	64.6 kg n=1545 Participants • Some late presenters had incomplete measurements	64.4 kg n=445 Participants • Some late presenters had incomplete measurements	60.9 kg n=200 Participants • Some late presenters had incomplete measurements	64 kg n=3737 Participants • Some late presenters had incomplete measurements
BMI	25.9 kg/m^2 n=1545 Participants • Some participants had incomplete measurements for either weight, height, or both.	26.3 kg/m^2 n=1535 Participants • Some participants had incomplete measurements for either weight, height, or both.	26.3 kg/m^2 n=442 Participants • Some participants had incomplete measurements for either weight, height, or both.	23.6 kg/m^2 n=198 Participants • Some participants had incomplete measurements for either weight, height, or both.	26 kg/m^2 n=3720 Participants • Some participants had incomplete measurements for either weight, height, or both.
HIV RNA level prior to randomization	6409 copies/ml n=1540 Participants • Baseline HIV RNA data was incomplete for some participants.	8002 copies/ml n=1542 Participants • Baseline HIV RNA data was incomplete for some participants.	8393 copies/ml n=445 Participants • Baseline HIV RNA data was incomplete for some participants.	12140 copies/ml n=196 Participants • Baseline HIV RNA data was incomplete for some participants.	7409 copies/ml n=3723 Participants • Baseline HIV RNA data was incomplete for some participants.
Viral Load at enrollment	3.8 log10 copies/mL n=1540 Participants • Baseline HIV RNA data was incomplete for some participants.	3.9 log10 copies/mL n=1542 Participants • Baseline HIV RNA data was incomplete for some participants.	3.9 log10 copies/mL n=445 Participants • Baseline HIV RNA data was incomplete for some participants.	4.1 log10 copies/mL n=196 Participants • Baseline HIV RNA data was incomplete for some participants.	3.9 log10 copies/mL n=3723 Participants • Baseline HIV RNA data was incomplete for some participants.
CD4 count at screening	534 cells/mm^3 n=1547 Participants	526 cells/mm^3 n=1545 Participants	538 cells/mm^3 n=445 Participants	520 cells/mm^3 n=204 Participants	530 cells/mm^3 n=3741 Participants
ALT (SGPT)	12 units/liter n=1547 Participants • Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.	12 units/liter n=1545 Participants • Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.	12 units/liter n=445 Participants • Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.	16.5 units/liter n=196 Participants • Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.	12 units/liter n=3733 Participants • Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.
Hemoglobin	11 g/dl n=1547 Participants	11.1 g/dl n=1545 Participants	11 g/dl n=445 Participants	10.6 g/dl n=204 Participants	11 g/dl n=3741 Participants
WBC	6800 (cells/mm^3) n=1547 Participants • Baseline White Blood Cell (WBC) values were incomplete for some participants.	6900 (cells/mm^3) n=1545 Participants • Baseline White Blood Cell (WBC) values were incomplete for some participants.	6840 (cells/mm^3) n=445 Participants • Baseline White Blood Cell (WBC) values were incomplete for some participants.	8660 (cells/mm^3) n=196 Participants • Baseline White Blood Cell (WBC) values were incomplete for some participants.	6900 (cells/mm^3) n=3733 Participants • Baseline White Blood Cell (WBC) values were incomplete for some participants.
Absolute Neutrophil Count at Baseline	4140 cells/mm^3 n=1547 Participants • Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.	4209 cells/mm^3 n=1545 Participants • Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.	3990 cells/mm^3 n=445 Participants • Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.	5680 cells/mm^3 n=196 Participants • Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.	4220 cells/mm^3 n=3733 Participants • Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.
Platelet count	238000 cells/mm^3 n=1547 Participants • Baseline platelet counts were incomplete for some participants.	236000 cells/mm^3 n=1544 Participants • Baseline platelet counts were incomplete for some participants.	242500 cells/mm^3 n=444 Participants • Baseline platelet counts were incomplete for some participants.	255000 cells/mm^3 n=195 Participants • Baseline platelet counts were incomplete for some participants.	239000 cells/mm^3 n=3730 Participants • Baseline platelet counts were incomplete for some participants.
Serum Creatinine	0.5 mg/dL n=1547 Participants • Baseline Serum Creatinine values were incomplete for some participants.	0.5 mg/dL n=1545 Participants • Baseline Serum Creatinine values were incomplete for some participants.	0.5 mg/dL n=445 Participants • Baseline Serum Creatinine values were incomplete for some participants.	0.6 mg/dL n=199 Participants • Baseline Serum Creatinine values were incomplete for some participants.	0.5 mg/dL n=3736 Participants • Baseline Serum Creatinine values were incomplete for some participants.
WHO Clinical Staging of HIV/AIDS Clinical stage I	1493 Participants n=1544 Participants • Baseline WHO staging category was incomplete for some participants.	1506 Participants n=1542 Participants • Baseline WHO staging category was incomplete for some participants.	434 Participants n=445 Participants • Baseline WHO staging category was incomplete for some participants.	165 Participants n=169 Participants • Baseline WHO staging category was incomplete for some participants.	3598 Participants n=3700 Participants • Baseline WHO staging category was incomplete for some participants.
WHO Clinical Staging of HIV/AIDS Clinical stage II	50 Participants n=1544 Participants • Baseline WHO staging category was incomplete for some participants.	34 Participants n=1542 Participants • Baseline WHO staging category was incomplete for some participants.	11 Participants n=445 Participants • Baseline WHO staging category was incomplete for some participants.	4 Participants n=169 Participants • Baseline WHO staging category was incomplete for some participants.	99 Participants n=3700 Participants • Baseline WHO staging category was incomplete for some participants.
WHO Clinical Staging of HIV/AIDS Clinical stage III	1 Participants n=1544 Participants • Baseline WHO staging category was incomplete for some participants.	2 Participants n=1542 Participants • Baseline WHO staging category was incomplete for some participants.	0 Participants n=445 Participants • Baseline WHO staging category was incomplete for some participants.	0 Participants n=169 Participants • Baseline WHO staging category was incomplete for some participants.	3 Participants n=3700 Participants • Baseline WHO staging category was incomplete for some participants.
Calculated Creatinine Clearance (ml/min) <= 50 ml/min	0 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	0 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	0 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	1 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	1 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Calculated Creatinine Clearance (ml/min) > 50 - 60 ml/min	1 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	0 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	1 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	1 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	3 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Calculated Creatinine Clearance (ml/min) > 60 - 80 ml/min	5 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	5 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	2 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	2 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	14 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Calculated Creatinine Clearance (ml/min) > 80 - 100 ml/min	27 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	31 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	6 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	10 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	74 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Calculated Creatinine Clearance (ml/min) > 100 - 120 ml/min	90 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	108 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	39 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	31 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	268 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Calculated Creatinine Clearance (ml/min) > 120 ml/min	1424 Participants n=1547 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	1401 Participants n=1545 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	397 Participants n=445 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	154 Participants n=199 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants	3376 Participants n=3736 Participants • Baseline Calculated Creatinine Clearance values were incomplete for some participants
Gestational age at study entry (weeks)	25.7 weeks n=1547 Participants • Baseline gestational age was incomplete for some participants.	25.2 weeks n=1544 Participants • Baseline gestational age was incomplete for some participants.	26 weeks n=445 Participants • Baseline gestational age was incomplete for some participants.	38.6 weeks n=194 Participants • Baseline gestational age was incomplete for some participants.	25.6 weeks n=3730 Participants • Baseline gestational age was incomplete for some participants.
Gestational age at study entry <14 weeks	10 Participants n=1547 Participants • Baseline gestational age was incomplete for some participants.	8 Participants n=1544 Participants • Baseline gestational age was incomplete for some participants.	2 Participants n=445 Participants • Baseline gestational age was incomplete for some participants.	0 Participants n=10 Participants • Baseline gestational age was incomplete for some participants.	20 Participants n=3546 Participants • Baseline gestational age was incomplete for some participants.
Gestational age at study entry 14 - <28 weeks	956 Participants n=1547 Participants • Baseline gestational age was incomplete for some participants.	1008 Participants n=1544 Participants • Baseline gestational age was incomplete for some participants.	264 Participants n=445 Participants • Baseline gestational age was incomplete for some participants.	0 Participants n=10 Participants • Baseline gestational age was incomplete for some participants.	2228 Participants n=3546 Participants • Baseline gestational age was incomplete for some participants.
Gestational age at study entry 28 - <34 weeks	418 Participants n=1547 Participants • Baseline gestational age was incomplete for some participants.	368 Participants n=1544 Participants • Baseline gestational age was incomplete for some participants.	116 Participants n=445 Participants • Baseline gestational age was incomplete for some participants.	1 Participants n=10 Participants • Baseline gestational age was incomplete for some participants.	903 Participants n=3546 Participants • Baseline gestational age was incomplete for some participants.
Gestational age at study entry 34 - < 37 weeks	117 Participants n=1547 Participants • Baseline gestational age was incomplete for some participants.	113 Participants n=1544 Participants • Baseline gestational age was incomplete for some participants.	45 Participants n=445 Participants • Baseline gestational age was incomplete for some participants.	0 Participants n=10 Participants • Baseline gestational age was incomplete for some participants.	275 Participants n=3546 Participants • Baseline gestational age was incomplete for some participants.
Gestational age at study entry >= 37 weeks	46 Participants n=1547 Participants • Baseline gestational age was incomplete for some participants.	47 Participants n=1544 Participants • Baseline gestational age was incomplete for some participants.	18 Participants n=445 Participants • Baseline gestational age was incomplete for some participants.	9 Participants n=10 Participants • Baseline gestational age was incomplete for some participants.	120 Participants n=3546 Participants • Baseline gestational age was incomplete for some participants.
The Most Complex ARV Regimen for Prior PMTCT HAART including NNRTI	7 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	5 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	2 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	14 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Most Complex ARV Regimen for Prior PMTCT sdNVP+ZDV	33 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	48 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	6 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	87 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Most Complex ARV Regimen for Prior PMTCT sdNVP	41 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	46 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	15 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	2 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	104 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Most Complex ARV Regimen for Prior PMTCT One PI	0 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	1 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	1 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Most Complex ARV Regimen for Prior PMTCT One NRTI	2 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	2 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	0 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	4 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Most Complex ARV Regimen for Prior PMTCT No ARVs for prior PMTCT/no prior pregnancy	1456 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	1442 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	422 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	202 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor	3522 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, ZDV - Zidovudine, NVP - Nevirapine, NRTI - Nucleoside Reverse Transcriptase Inhibitor
The Last ARV Regimen before Entry during the Current Pregnancy HAART including NNRTI	1 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	1 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	0 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	7 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	9 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine
The Last ARV Regimen before Entry during the Current Pregnancy Two NRTIs	2 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	5 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	3 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	10 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	20 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine
The Last ARV Regimen before Entry during the Current Pregnancy sdNVP+ZDV	2 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	0 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	0 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	1 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	3 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine
The Last ARV Regimen before Entry during the Current Pregnancy sdNVP	5 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	2 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	0 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	33 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	40 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine
The Last ARV Regimen before Entry during the Current Pregnancy No ARVs during the current pregnancy	1203 Participants n=1539 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	1200 Participants n=1544 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	317 Participants n=445 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	153 Participants n=204 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine	2873 Participants n=3732 Participants • Baseline ARV history data were incomplete for some participants. NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, NRTI - Nucleoside Reverse Transcriptase Inhibitor, NVP - Nevirapine, ZDV - Zidovudine

PRIMARY outcome

Timeframe: Measured at birth or Week 1 study visit

Population: Analysis includes data from periods 1 and 2. Analysis is among the live births with HIV test results summarized for the maternal-infant set (the worst outcome summarized for cases of multiple births). Analysis used the principle of intent to treat.

Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point

Outcome measures

Measure	Antepartum Arm A n=1386 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1385 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=325 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Number of Confirmed Infant HIV Infections	25 Participants	7 Participants	2 Participants

PRIMARY outcome

Timeframe: Measured through the Week 1 postpartum study visit

Population: Mothers with no safety data available after baseline were not included. Analysis used the principle of intent to treat.

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).

Outcome measures

Measure	Antepartum Arm A n=1521 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1520 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=424 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events Periods 1 and 2	261 Participants	318 Participants	—
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events Period 2	59 Participants	61 Participants	60 Participants

PRIMARY outcome

Timeframe: Measured through the Week 1 postpartum study visit

Population: Mothers who do not have any obstetrical complications information available after study entry are not included. Analysis used the principle of intent to treat.

Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as "Pregnancy, puerperium and perinatal conditions", except if the condition was the death of the fetus: "Abortions not specified as induced or spontaneous", "Abortions spontaneous", or "Stillbirth and foetal death."

Outcome measures

Measure	Antepartum Arm A n=1521 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1520 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=424 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Number of Mothers With Obstetrical Complications Periods 1 and 2	89 Participants	75 Participants	—
Antepartum Component: Number of Mothers With Obstetrical Complications Period 2	20 Participants	12 Participants	23 Participants

PRIMARY outcome

Timeframe: Measured at birth

Population: Includes mothers with confirmed infant birth outcome as live birth, stillbirth, or spontaneous abortion and outcome assessments. Multiple gestation pregnancies (twins and triplets) were summarized at the unique mother level. Analysis used the principle of intent to treat.

Composite outcome

Outcome measures

Measure	Antepartum Arm A n=1451 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1447 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=372 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) Periods 1 and 2	389 Participants	563 Participants	—
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) Period 2	91 Participants	123 Participants	111 Participants

PRIMARY outcome

Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

Population: All Mother-Infant (M-I) pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 35 M-I pairs with no post-randomization HIV test results were included and censored at the date of randomization in the analyses. Analyses were intent to treat.

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.

Outcome measures

Measure	Antepartum Arm A n=1219 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1211 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Postpartum Component: Incidence of Confirmed Infant HIV Infection	0.56 New cases per 100 person-years	0.55 New cases per 100 person-years	—

PRIMARY outcome

Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first

Population: All mothers were included in the analyses. 15 mothers with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.

These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).

Outcome measures

Measure	Antepartum Arm A n=1220 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1211 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events	14.4 New cases per 100 person-years	14.1 New cases per 100 person-years	—

PRIMARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death	0.24 New cases per 100 person-years	0.49 New cases per 100 person-years	—

SECONDARY outcome

Timeframe: Measured at the birth (<= 3 days postpartum) visit

Population: Analysis is among the live births with HIV test results summarized in the maternal-infant set (the worst outcome summarized for multiple births to the same mother). Analysis used the principle of intent to treat.

Detected by HIV NAT positivity

Outcome measures

Measure	Antepartum Arm A n=1386 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1385 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=325 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Number of Infant HIV Infections	22 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Measured from birth through 104 weeks of age

Population: Infants in the antepartum component not excluded from analysis; only one infant was included per pregnancy, the one with the earliest failure time. The Periods 1\&2 group is infants born to mothers randomized in Arms A and B throughout the PROMISE study (both protocol versions). The period 2 group includes infants born to mothers randomized during the last protocol version only. Since Arm C was only available to all under the last protocol version, this enables unbiased comparison with Arm C.

For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function.

Outcome measures

Measure	Antepartum Arm A n=1475 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1459 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=389 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) Overall survival, Periods 1 & 2 group (arms A & B only)	0.959 Proportional probability Interval 0.948 to 0.969	0.967 Proportional probability Interval 0.955 to 0.975	—
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) Overall survival, period 2 group	0.951 Proportional probability Interval 0.92 to 0.97	0.982 Proportional probability Interval 0.962 to 0.991	0.942 Proportional probability Interval 0.914 to 0.962
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) HIV-free survival, Periods 1&2 group (arms A&B only)	0.937 Proportional probability Interval 0.923 to 0.948	0.947 Proportional probability Interval 0.933 to 0.958	—
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) HIV-free survival, period 2 group	0.936 Proportional probability Interval 0.903 to 0.958	0.940 Proportional probability Interval 0.864 to 0.975	0.921 Proportional probability Interval 0.887 to 0.946

SECONDARY outcome

Timeframe: Measured at the time of delivery

Population: Analysis includes only mothers with HIV RNA data at delivery. Analysis used the principle of intent to treat.

Analysis used the principle of intent to treat.

Outcome measures

Measure	Antepartum Arm A n=1547 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1545 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C n=445 Participants Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery Periods 1 and 2 · HIV RNA < 400 copies/mL	415 Participants	1092 Participants	—
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery Periods 1 and 2 · HIV RNA >= 400 copies/mL	929 Participants	275 Participants	—
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery Period 2 · HIV RNA < 400 copies/mL	102 Participants	259 Participants	225 Participants
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery Period 2 · HIV RNA >= 400 copies/mL	210 Participants	62 Participants	79 Participants

SECONDARY outcome

Timeframe: Measured through 24 months post-delivery

Population: All M-I pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 3 M-I pairs with no post-randomization data were included and censored at the date of randomization. Analyses were intent to treat.

Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.

Outcome measures

Measure	Antepartum Arm A n=1219 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1211 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery	0.971 Probability Interval 0.959 to 0.98	0.977 Probability Interval 0.966 to 0.985	—

SECONDARY outcome

Timeframe: Measured at 12 and 24 months post-delivery

Population: All live-born infants were included in the analyses. 4 infants with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.

Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair)

Outcome measures

Measure	Antepartum Arm A n=1227 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1217 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery 24 months post delivery	0.978 Probability Interval 0.967 to 0.986	0.987 Probability Interval 0.979 to 0.992	—
Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery 12 months post delivery	0.988 Probability Interval 0.98 to 0.993	0.989 Probability Interval 0.981 to 0.994	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of Death	0.24 New cases per 100 person-years Interval 0.18 to 0.32	0.43 New cases per 100 person-years Interval 0.36 to 0.52	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

"AIDS-defining illness" refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of AIDS-defining Illness	0.08 New cases per 100 person-years Interval 0.05 to 0.12	0.25 New cases per 100 person-years Interval 0.2 to 0.3	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of HIV/AIDS-related Events	1.14 New cases per 100 person-years Interval 0.89 to 1.45	1.24 New cases per 100 person-years Interval 1.02 to 1.52	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.

Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy.

Outcome measures

Measure	Antepartum Arm A n=794 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events	2.9 events per 100 person-years Interval 2.3 to 3.8	5.7 events per 100 person-years Interval 4.8 to 6.7	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others.

Outcome measures

Measure	Antepartum Arm A n=794 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Other Targeted Medical Conditions	4.0 events per 100 person-years Interval 3.2 to 4.9	4.6 events per 100 person-years Interval 3.9 to 5.5	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of HIV/AIDS-related Event or Death	1.30 New cases per 100 person-years Interval 1.03 to 1.65	1.43 New cases per 100 person-years Interval 1.17 to 1.74	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events	3.47 New cases per 100 person-years Interval 2.8 to 4.31	5.61 New cases per 100 person-years Interval 4.83 to 6.53	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.

Outcome measures

Measure	Antepartum Arm A n=794 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern	9.0 events per 100 person-years Interval 7.3 to 10.9	14.0 events per 100 person-years Interval 12.1 to 16.1	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

Incidence of tuberculosis.

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence of Tuberculosis	0.40 New cases per 100 person-years Interval 0.32 to 0.51	0.31 New cases per 100 person-years Interval 0.24 to 0.39	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).

Outcome measures

Measure	Antepartum Arm A n=797 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results	15.3 New cases per 100 person-years Interval 12.8 to 18.1	13.9 New cases per 100 person-years Interval 11.9 to 16.3	—

SECONDARY outcome

Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.

Population: This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.

This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 ("Severe"). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic.

Outcome measures

Measure	Antepartum Arm A n=794 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=805 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event	0.5 events per 100 person-years Interval 0.4 to 0.6	0.9 events per 100 person-years Interval 0.7 to 1.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From study entry until July 7, 2015.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From study entry until July 7, 2015.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since inflammation and thrombogenic markers were not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From study entry until July 7, 2015.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since quality of life was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From study entry until July 7, 2015.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From study entry until July 7, 2015.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since functional maternal antibody and HIV-envelope binding responses were not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since pharmacokinetics was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at the end of the 5-year study period

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at the end of the 5-year study period

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).

Population: Women or infants in the postpartum component who had been included in the primary efficacy analysis (outcome measure #5 above), i.e., who had not yet reached the site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first, and whose adherence questionnaire was filled out.

Adherence is by maternal report; adherence through hair analysis is not included here.

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.

Outcome measures

Measure	Antepartum Arm A n=1220 Participants Mothers Received ZDV+sdNVP+TRV Tail	Antepartum Arm B n=1211 Participants Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Antepartum Arm C Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 6 visit · Never missed a dose	1003 Participants	1104 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 6 visit · Missed dose over 1 month ago	12 Participants	0 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 6 visit · Missed dose 2-4 weeks ago	17 Participants	4 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 6 visit · Missed dose within last 2 weeks	140 Participants	74 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 14 visit · Never missed a dose	956 Participants	1081 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 14 visit · Missed dose over 1 month ago	20 Participants	0 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 14 visit · Missed dose 2-4 weeks ago	35 Participants	9 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 14 visit · Missed dose within last 2 weeks	112 Participants	50 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 26 visit · Never missed a dose	888 Participants	1035 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 26 visit · Missed dose over 1 month ago	48 Participants	1 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 26 visit · Missed dose 2-4 weeks ago	31 Participants	8 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 26 visit · Missed dose within last 2 weeks	103 Participants	47 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 50 visit · Never missed a dose	716 Participants	841 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 50 visit · Missed dose over 1 month ago	37 Participants	9 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 50 visit · Missed dose 2-4 weeks ago	34 Participants	7 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 50 visit · Missed dose within last 2 weeks	64 Participants	30 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 74 visit · Never missed a dose	311 Participants	377 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 74 visit · Missed dose over 1 month ago	15 Participants	2 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 74 visit · Missed dose 2-4 weeks ago	17 Participants	1 Participants	—
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures Week 74 visit · Missed dose within last 2 weeks	34 Participants	9 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Week 8

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since changes in HBV DNA Viral Load was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at the end of the 5-year study period

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since cost effectiveness was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at the end of the 5-year study period

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since viral resistance was not a focus of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured through the Week 1 postpartum study visit

The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since adherence was not a focus of the study.

Outcome measures

Outcome data not reported

Adverse Events

Mother, (AP) ZDV+sdNVP+TRV Tail

Serious events: 267 serious events

Other events: 1413 other events

Deaths: 9 deaths

Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV)

Serious events: 276 serious events

Other events: 1414 other events

Deaths: 14 deaths

Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV)

Serious events: 69 serious events

Other events: 388 other events

Deaths: 2 deaths

Mother, LP

Serious events: 10 serious events

Other events: 169 other events

Deaths: 3 deaths

Infant, (Mother Received ZDV+sdNVP+TRV Tail)

Serious events: 296 serious events

Other events: 1406 other events

Deaths: 59 deaths

Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV))

Serious events: 287 serious events

Other events: 1388 other events

Deaths: 46 deaths

Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV))

Serious events: 113 serious events

Other events: 403 other events

Deaths: 27 deaths

Infant, LP

Serious events: 20 serious events

Other events: 170 other events

Deaths: 5 deaths

Serious adverse events

Measure	Mother, (AP) ZDV+sdNVP+TRV Tail n=1547 participants at risk Mothers received ZDV+sdNVP+TRV tail	Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) n=1545 participants at risk Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV) n=445 participants at risk Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Mother, LP n=204 participants at risk Registrational component to assess entry criteria for possible randomization in the Postpartum Component	Infant, (Mother Received ZDV+sdNVP+TRV Tail) n=1500 participants at risk Mothers received ZDV+sdNVP+TRV tail	Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV)) n=1478 participants at risk Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV)) n=429 participants at risk Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Infant, LP n=204 participants at risk Registrational component to assess entry criteria for possible randomization in the Postpartum Component
Pregnancy, puerperium and perinatal conditions Umbilical granuloma	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Blood and lymphatic system disorders Anaemia	0.84% 13/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.0% 16/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.90% 4/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.5% 3/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.67% 10/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.74% 11/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Blood and lymphatic system disorders Neutropenia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Cardiac disorders Extrasystoles	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Cardiac disorders Pulmonary valve stenosis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Ankyloglossia congenital	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Cleft palate	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital anaemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital anomaly	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital genital malformation male	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital inguinal hernia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital malaria	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital megacolon	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital musculoskeletal anomaly	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital pneumonia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital rubella infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital syphilis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Craniosynostosis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Dermoid cyst	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Exomphalos	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Gastroschisis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Genitalia external ambiguous	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Holoprosencephaly	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Hypospadias	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Laryngomalacia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Macrocephaly	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Meningomyelocele	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Micrognathia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Multiple congenital abnormalities	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Multiple gastrointestinal atresias	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Patent ductus arteriosus	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Persistent foetal circulation	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Sickle cell anaemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Talipes	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Ventricular septal defect	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Eye disorders Cataract	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Eye disorders Conjunctival haemorrhage	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Eye disorders Strabismus	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Abdominal distension	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Abdominal mass	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Abdominal pain	0.26% 4/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Abdominal pain lower	0.26% 4/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Ascites	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Diarrhoea	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Femoral hernia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Gastritis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Haemorrhoids	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Ileus	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Ileus paralytic	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Necrotising colitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.40% 6/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Peptic ulcer	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Small intestinal obstruction	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Umbilical hernia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Vomiting	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
General disorders Death	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.70% 3/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
General disorders Infusion site extravasation	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
General disorders Pyrexia	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
General disorders Sudden infant death syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Hepatitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Hepatotoxicity	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Jaundice	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Abscess	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Abscess neck	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Amniotic cavity infection	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Anal abscess	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Appendicitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Arthritis bacterial	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bacteraemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bacterial infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bacterial sepsis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bartholin's abscess	0.26% 4/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Brain abscess	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Breast abscess	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bronchiolitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.53% 8/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.54% 8/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Bullous impetigo	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Cellulitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Cervicitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Conjunctivitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Disseminated tuberculosis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Dysentery	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Encephalitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Enterobacter sepsis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Gastroenteritis	0.32% 5/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.65% 10/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 29/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.8% 26/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 8/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Giardiasis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Lower respiratory tract infection	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.40% 6/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Malaria	0.58% 9/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.39% 6/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.90% 4/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.61% 9/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.70% 3/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Measles	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Meningitis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Meningitis bacterial	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Meningitis cryptococcal	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Meningitis tuberculous	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Meningitis viral	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Neonatal pneumonia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Neurosyphilis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Ophthalmia neonatorum	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Otitis media	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pelvic abscess	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pelvic infection	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pelvic inflammatory disease	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pertussis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pharyngitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Plasmodium falciparum infection	0.32% 5/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 7/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.34% 5/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Plasmodium malariae infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pneumonia	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.32% 5/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.3% 34/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.2% 33/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 8/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.9% 6/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pneumonia bacterial	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.5% 23/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.0% 15/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.2% 5/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Post procedural sepsis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Postoperative wound infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Postpartum sepsis	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pulmonary tuberculosis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pyelonephritis	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Respiratory tract infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Rhinitis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Salmonella sepsis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Salpingitis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Sepsis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.60% 9/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Sepsis neonatal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.1% 47/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.2% 33/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.6% 11/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.5% 3/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Sexually transmitted disease	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Staphylococcal scalded skin syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Staphylococcal sepsis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Staphylococcal skin infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Subcutaneous abscess	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Tuberculosis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Upper respiratory tract infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Urinary tract infection	0.78% 12/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.52% 8/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.90% 4/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Vaginal infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Viral infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Vulvovaginitis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Vulvovaginitis trichomonal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Wound infection	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Wound sepsis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Bladder injury	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Burns first degree	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Burns second degree	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Forearm fracture	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Head injury	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Herbal toxicity	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Penetrating abdominal trauma	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Cerebrovascular accident	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Post procedural complication	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Soft tissue injury	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Uterine dehiscence	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Uterine rupture	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Vaginal laceration	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Injury, poisoning and procedural complications Wound dehiscence	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Alanine aminotransferase increased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.32% 5/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Amniotic fluid volume decreased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Aspartate aminotransferase increased	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Blood creatinine increased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Foetal non-stress test abnormal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Haemoglobin decreased	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Hepatic enzyme increased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Liver function test increased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Neutrophil count decreased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Transaminases increased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Weight decreased	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Dehydration	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Diabetes mellitus	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Hypoglycaemia neonatal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Malnutrition	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.5% 22/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.4% 20/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.6% 11/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Marasmus	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Poor feeding infant	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Vitamin K deficiency	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Musculoskeletal and connective tissue disorders Symphysiolysis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Aphasia	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Cerebral infarction	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Convulsion neonatal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Dizziness	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Encephalopathy neonatal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Facial paralysis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Febrile convulsion	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Headache	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Hemiparesis	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Hydrocephalus	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Migraine	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Seizure	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion complete	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.26% 4/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.45% 7/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.32% 5/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Eclampsia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions False labour	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Foetal death	1.6% 25/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.4% 37/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.6% 7/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Foetal distress syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Foetal growth restriction	0.32% 5/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Gestational hypertension	1.2% 18/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.58% 9/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.3% 6/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions HELLP syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Haemorrhage in pregnancy	0.58% 9/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Intrapartum haemorrhage	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.40% 6/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Labour pain	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Low birth weight baby	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.41% 6/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.2% 5/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Meconium in amniotic fluid	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Obstructed labour	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Oligohydramnios	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Peripartum cardiomyopathy	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Placenta accreta	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Placental insufficiency	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Polyhydramnios	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.71% 11/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.71% 11/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.97% 15/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.0% 16/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.67% 3/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.7% 25/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.8% 42/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.4% 19/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Premature delivery	0.58% 9/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.67% 3/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Premature labour	1.0% 16/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.97% 15/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.8% 8/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.65% 10/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.91% 14/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.39% 6/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Preterm premature rupture of membranes	0.45% 7/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.67% 3/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Prolonged labour	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Retained placenta or membranes	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Retained products of conception	0.39% 6/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Stillbirth	0.32% 5/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.58% 9/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Threatened labour	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Umbilical cord around neck	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Umbilical cord prolapse	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Vomiting in pregnancy	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Brief psychotic disorder, with postpartum onset	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Confusional state	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Conversion disorder	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Intentional self-injury	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.26% 4/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Major depression	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Mental disorder	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Psychiatric disorders Psychotic disorder	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Acute kidney injury	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Anuria	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Chronic kidney disease	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Renal failure	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Urinary retention	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Cervix disorder	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Ovarian cyst	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Uterine atony	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Vaginal haemorrhage	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Vulval haemorrhage	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Allergic respiratory disease	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Asthma	0.19% 3/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Meconium aspiration syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 7/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.73% 11/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.3% 10/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.53% 8/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 7/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.4% 6/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 7/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.33% 5/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.47% 2/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Blister	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Umbilical haemorrhage	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Urticaria	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Surgical and medical procedures Abortion induced	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Surgical and medical procedures Acrochordon excision	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Surgical and medical procedures Hospitalisation	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Surgical and medical procedures Infection prophylaxis	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Surgical and medical procedures Psychosocial support	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.06% 1/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Deep vein thrombosis	0.13% 2/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.22% 1/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Haematoma	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Haemorrhage	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Hypertension	0.39% 6/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.19% 3/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Hypotension	0.06% 1/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Subgaleal haematoma	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).

Other adverse events

Measure	Mother, (AP) ZDV+sdNVP+TRV Tail n=1547 participants at risk Mothers received ZDV+sdNVP+TRV tail	Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV) n=1545 participants at risk Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV) n=445 participants at risk Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Mother, LP n=204 participants at risk Registrational component to assess entry criteria for possible randomization in the Postpartum Component	Infant, (Mother Received ZDV+sdNVP+TRV Tail) n=1500 participants at risk Mothers received ZDV+sdNVP+TRV tail	Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV)) n=1478 participants at risk Mothers received Triple ARV (3TC-ZDV/LPV-RTV)	Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV)) n=429 participants at risk Mothers received Triple ARV (FTC-TDF/LPV-RTV)	Infant, LP n=204 participants at risk Registrational component to assess entry criteria for possible randomization in the Postpartum Component
Blood and lymphatic system disorders Iron deficiency anaemia	2.2% 34/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.1% 33/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.67% 3/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 10/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 96/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.5% 81/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.4% 6/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 18/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Congenital, familial and genetic disorders Congenital umbilical hernia	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.2% 93/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.0% 89/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.9% 34/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Eye disorders Eye discharge	0.45% 7/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.39% 6/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.6% 99/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 94/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.6% 11/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 13/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Abdominal pain	10.8% 167/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	10.6% 164/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 21/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.4% 9/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.80% 12/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.95% 14/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.70% 3/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Diarrhoea	11.6% 179/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	13.1% 202/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.2% 41/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 5/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	20.5% 307/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	21.4% 317/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	12.1% 52/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.8% 16/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Gastritis	4.7% 72/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.1% 63/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.4% 24/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 13/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.14% 2/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Gastrointestinal disorders Vomiting	5.2% 81/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.8% 90/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.3% 19/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.1% 107/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.2% 106/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.4% 19/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.9% 6/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
General disorders Pyrexia	7.6% 118/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.0% 92/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.8% 26/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	17.3% 260/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	16.2% 240/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	11.2% 48/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 18/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Body tinea	5.2% 81/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.4% 84/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.0% 18/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.4% 9/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.3% 80/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.0% 74/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.8% 12/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.9% 8/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Conjunctivitis	2.4% 37/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 30/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.2% 10/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.9% 6/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.6% 99/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.1% 75/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 20/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.9% 8/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Gastroenteritis	7.2% 111/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.5% 101/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.6% 25/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	10.3% 21/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	15.1% 227/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	13.9% 205/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	13.5% 58/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	18.6% 38/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Malaria	5.5% 85/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.1% 79/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.8% 17/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 103/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 95/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.8% 29/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Ophthalmia neonatorum	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.1% 61/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.8% 71/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.6% 11/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.4% 15/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Oral candidiasis	0.84% 13/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.52% 8/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.3% 124/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.6% 112/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	10.3% 44/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 14/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Otitis media acute	0.65% 10/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.71% 11/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.8% 8/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 74/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.2% 62/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.0% 30/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pharyngitis	5.7% 88/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.0% 92/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 21/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.9% 12/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 37/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.4% 35/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.2% 5/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Plasmodium falciparum infection	4.5% 70/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 75/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.1% 14/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.5% 3/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 103/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 95/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.6% 11/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Pneumonia bacterial	1.2% 18/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.6% 25/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.9% 6/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.3% 94/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.7% 84/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.8% 25/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 5/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Urinary tract infection	11.4% 177/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	10.0% 154/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	11.7% 52/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.53% 8/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.0% 15/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 8/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Infections and infestations Vulvovaginal candidiasis	14.8% 229/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	13.3% 206/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	15.3% 68/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 14/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Alanine aminotransferase increased	30.4% 470/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	31.9% 493/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	26.1% 116/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	17.6% 36/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.1% 106/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.5% 66/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.8% 12/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 14/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Aspartate aminotransferase increased	4.4% 68/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.7% 88/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.5% 29/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.9% 12/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.20% 3/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Blood albumin decreased	3.9% 61/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.5% 85/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	11.2% 50/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.9% 8/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.33% 5/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.34% 5/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.70% 3/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Haemoglobin decreased	49.4% 764/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	51.2% 791/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	42.9% 191/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	50.5% 103/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	81.7% 1226/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	83.2% 1230/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	83.0% 356/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	60.8% 124/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Hormone level abnormal	1.6% 25/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 30/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 11/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.4% 15/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Neutrophil count decreased	43.2% 668/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	40.1% 619/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	36.2% 161/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	32.8% 67/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	57.3% 859/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	57.4% 848/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	59.4% 255/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	56.4% 115/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Platelet count decreased	9.8% 151/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.3% 144/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.2% 41/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 18/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.3% 94/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.4% 94/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.3% 40/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.4% 9/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations Weight decreased	7.2% 112/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.5% 85/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 21/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 10/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.9% 29/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.4% 20/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.7% 16/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Investigations White blood cell count decreased	4.3% 66/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.5% 54/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.4% 15/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.9% 12/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.80% 12/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.27% 4/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.70% 3/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.5% 53/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.7% 40/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.3% 14/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.9% 14/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Musculoskeletal and connective tissue disorders Growth failure	0.00% 0/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.2% 63/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 72/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.9% 38/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 4/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Nervous system disorders Headache	12.2% 189/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	12.2% 188/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.2% 23/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.9% 8/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Pregnancy, puerperium and perinatal conditions Pregnancy	17.6% 272/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	17.5% 271/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	11.7% 52/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	12.7% 26/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Renal and urinary disorders Dysuria	5.2% 80/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.0% 78/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 9/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.13% 2/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.23% 1/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Reproductive system and breast disorders Vaginal discharge	7.5% 116/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 136/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 21/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 5/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.07% 1/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Cough	11.6% 179/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	11.2% 173/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.5% 20/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.9% 6/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	18.3% 274/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	17.1% 253/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.2% 35/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.3% 17/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 20/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.84% 13/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.2% 78/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.4% 80/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.0% 30/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 5/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.2% 81/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.0% 93/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.7% 12/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.6% 144/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.3% 138/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.4% 23/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.9% 8/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Rash	4.1% 64/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.5% 69/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	1.8% 8/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	9.3% 139/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 130/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.7% 20/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.5% 5/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Skin and subcutaneous tissue disorders Rash generalised	2.3% 35/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	2.0% 31/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.45% 2/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.49% 1/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	4.9% 73/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	5.0% 74/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	3.5% 15/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.98% 2/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
Vascular disorders Hypertension	7.7% 119/1547 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	7.8% 120/1545 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	6.1% 27/445 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	8.8% 18/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1500 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/1478 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/429 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).	0.00% 0/204 • From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first. Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).

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
• Publication restrictions are in place

Restriction type: OTHER