Trial Outcomes & Findings for Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment (NCT NCT02227238)

Last Updated: 2023-03-13

Results Overview

Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

627 participants

Primary outcome timeframe

Week 48

Results posted on

2023-03-13

Participant Flow

This study assessed antiviral activity and safety of dolutegravir (DTG) in human immunodeficiency virus-1 (HIV-1) infected participants with treatment failure on first line therapy. The study consisted of Randomized Phase followed by Continuation Phase.

A total of 627 participants were randomized in 1:1 to receive DTG or lopinavir/ritonavir (LPV/RTV). Three participants in the LPV/RTV group were randomized but not treated. A total of 624 participants received at least one dose of study medication creating the intent to treat-exposed (ITT-E) Population.

Participant milestones

Participant milestones
Measure	Participants Receiving DTG-Randomized Phase Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.	Participants Receiving DTG-Continuation Phase Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.
Randomized Phase (Up to Week 52) STARTED	312	315	0
Randomized Phase (Up to Week 52) ITT-E Population	312	312	0
Randomized Phase (Up to Week 52) COMPLETED	275	245	0
Randomized Phase (Up to Week 52) NOT COMPLETED	37	70	0
Continuation Phase(From Weeks 52 to 295) STARTED	0	0	274
Continuation Phase(From Weeks 52 to 295) COMPLETED	0	0	225
Continuation Phase(From Weeks 52 to 295) NOT COMPLETED	0	0	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Receiving DTG-Randomized Phase Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.	Participants Receiving DTG-Continuation Phase Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.
Randomized Phase (Up to Week 52) Reached stopping criteria	0	1	0
Randomized Phase (Up to Week 52) Adverse Event	8	18	0
Randomized Phase (Up to Week 52) Lack of Efficacy	10	22	0
Randomized Phase (Up to Week 52) Protocol Violation	7	8	0
Randomized Phase (Up to Week 52) Withdrawal by Subject	5	4	0
Randomized Phase (Up to Week 52) Physician Decision	0	9	0
Randomized Phase (Up to Week 52) Lost to Follow-up	7	5	0
Randomized Phase (Up to Week 52) Randomized, but did not receive treatment	0	3	0
Continuation Phase(From Weeks 52 to 295) Adverse Event	0	0	8
Continuation Phase(From Weeks 52 to 295) Lack of Efficacy	0	0	16
Continuation Phase(From Weeks 52 to 295) Protocol Violation	0	0	8
Continuation Phase(From Weeks 52 to 295) Withdrawal by Subject	0	0	6
Continuation Phase(From Weeks 52 to 295) Physician Decision	0	0	4
Continuation Phase(From Weeks 52 to 295) Lost to Follow-up	0	0	7

Baseline Characteristics

Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.	Total n=624 Participants Total of all reporting groups
Age, Continuous	37.5 Years STANDARD_DEVIATION 9.13 • n=5 Participants	38.7 Years STANDARD_DEVIATION 9.35 • n=7 Participants	38.1 Years STANDARD_DEVIATION 9.25 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	103 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	209 Participants n=7 Participants	405 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · American Indian or Alaska native	42 Participants n=5 Participants	53 Participants n=7 Participants	95 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · Asian- Central/South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · Asian - East Asian Heritage	21 Participants n=5 Participants	31 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · Asian - South East Asian Heritage	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · White - Arabic/North African Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · White - White/Caucasian/European Heritage	88 Participants n=5 Participants	90 Participants n=7 Participants	178 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · Mixed White Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race, customized · Black or African American Heritage	130 Participants n=5 Participants	112 Participants n=7 Participants	242 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48	84 Percentage of participants	70 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population

Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24	82 Percentage of participants	69 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: ITT-E Population

Percentage of participants with plasma HIV 1 RNA \<400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 Week 24	90 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 Week 48	88 Percentage of participants	77 Percentage of participants

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: ITT-E Population

Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 Week 24	97.6 Percentage of participants	91.9 Percentage of participants
Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 Week 48	96.0 Percentage of participants	86.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

Viral suppression was defined as HIV-1 RNA \<50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Time to Viral Suppression at Week 48	29.0 Days Interval 29.0 to 57.0	111.0 Days Interval 35.0 to 167.0

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 24 and Week 48

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 Week 24; n= 291, 285	84.0 Cells per cubic millimeter (Cells/mm^3) Interval 31.0 to 146.0	82.0 Cells per cubic millimeter (Cells/mm^3) Interval 31.0 to 146.0
Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 Week 48; n= 275, 251	120.0 Cells per cubic millimeter (Cells/mm^3) Interval 63.0 to 204.0	118.0 Cells per cubic millimeter (Cells/mm^3) Interval 66.0 to 191.0

SECONDARY outcome

Timeframe: Up to Week 348

Population: ITT-E Population

Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Disease Progression-Randomized + Continuation Phase	10 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Viral genotypic Population. Only those participants with data available at specified time point were analyzed.

Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=11 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=30 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase INSTI	3 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase NRTI	1 Participants	3 Participants
Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase PI	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 295

Population: Viral genotypic continuation Population. Only those participants with data available at specified time point were analyzed.

Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=16 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase INSTI	5 Participants	—
Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase NRTI	2 Participants	—
Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase PI	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and up to Week 52

Population: Viral Phenotypic Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.

Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=11 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=29 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase DTG; <1; n=11, 23	5 Participants	18 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase DTG; 1-<2; n=11, 23	2 Participants	5 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase DTG; 2-<4; n=11, 23	1 Participants	0 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase DTG; 4-<8; n=11, 23	0 Participants	0 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase DTG; >=8; n=11, 23	3 Participants	0 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase LPV/RTV; <1; n=11, 29	7 Participants	21 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase LPV/RTV; 1-<2; n=11, 29	4 Participants	8 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase LPV/RTV; 2-<4; n=11, 29	0 Participants	0 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase LPV/RTV; 4-<8; n=11, 29	0 Participants	0 Participants
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase LPV/RTV; >=8; n=11, 29	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and up to Week 295

Population: Viral Phenotypic continuation Population. Only those participants with data available at specified time point were analyzed.

Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=15 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase DTG; <1	8 Participants	—
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase DTG; 1-<2	3 Participants	—
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase DTG; 2-<4	0 Participants	—
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase DTG; 4-<8	0 Participants	—
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase DTG; >=8	4 Participants	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase Any non-serious AEs	155 Participants	202 Participants
Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase Any SAEs	20 Participants	20 Participants

SECONDARY outcome

Timeframe: Up to Week 295

Population: Safety-Continuation Population comprised all participants in the Safety Population who received at least one dose of Investigational Product after entering the Continuation Phase.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=274 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase Any non-serious AEs	150 Participants	—
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase Any SAEs	29 Participants	—

SECONDARY outcome

Timeframe: Up to Week 348

Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase Any non-serious AEs	218 Participants	213 Participants
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase Any SAEs	47 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Albumin Values Week 4; n= 306, 302	-0.39 Gram per liter Standard Deviation 2.554	-0.51 Gram per liter Standard Deviation 2.670
Change From Baseline in Albumin Values Week 8; n= 301, 298	0.09 Gram per liter Standard Deviation 2.792	-0.67 Gram per liter Standard Deviation 2.828
Change From Baseline in Albumin Values Week 16; n= 294, 292	0.50 Gram per liter Standard Deviation 3.148	-0.28 Gram per liter Standard Deviation 3.062
Change From Baseline in Albumin Values Week 24; n= 295, 286	0.63 Gram per liter Standard Deviation 3.326	-0.06 Gram per liter Standard Deviation 3.207
Change From Baseline in Albumin Values Week 36; n= 289, 276	0.76 Gram per liter Standard Deviation 3.479	-0.11 Gram per liter Standard Deviation 3.091
Change From Baseline in Albumin Values Week 48; n= 278, 247	0.71 Gram per liter Standard Deviation 3.250	0.11 Gram per liter Standard Deviation 2.912
Change From Baseline in Albumin Values Week 52; n= 276, 238	0.83 Gram per liter Standard Deviation 3.605	-0.15 Gram per liter Standard Deviation 3.142

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 48; n= 278, 247	12.92 Micromoles per liter Standard Deviation 9.412	6.15 Micromoles per liter Standard Deviation 13.373
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 16; n= 294, 292	2.79 Micromoles per liter Standard Deviation 4.547	3.97 Micromoles per liter Standard Deviation 4.957
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 4; n= 306, 302	9.68 Micromoles per liter Standard Deviation 9.308	4.69 Micromoles per liter Standard Deviation 8.575
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 8; n= 301, 298	10.81 Micromoles per liter Standard Deviation 8.414	5.57 Micromoles per liter Standard Deviation 9.214
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 16; n= 294, 292	12.46 Micromoles per liter Standard Deviation 9.065	5.19 Micromoles per liter Standard Deviation 9.648
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 24; n= 295, 286	12.96 Micromoles per liter Standard Deviation 10.248	5.75 Micromoles per liter Standard Deviation 11.606
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 36; n= 289, 276	12.08 Micromoles per liter Standard Deviation 9.667	5.98 Micromoles per liter Standard Deviation 14.737
Change From Baseline in Creatinine and Bilirubin Values Creatinine; Week 52; n= 276, 238	13.22 Micromoles per liter Standard Deviation 10.229	6.15 Micromoles per liter Standard Deviation 12.268
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 4; n= 305, 301	1.74 Micromoles per liter Standard Deviation 4.982	3.39 Micromoles per liter Standard Deviation 3.997
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 8; n= 301, 297	2.25 Micromoles per liter Standard Deviation 4.344	3.76 Micromoles per liter Standard Deviation 5.291
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 24; n= 295, 285	3.28 Micromoles per liter Standard Deviation 4.692	4.15 Micromoles per liter Standard Deviation 5.422
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 36; n= 289, 275	3.26 Micromoles per liter Standard Deviation 4.925	4.43 Micromoles per liter Standard Deviation 5.447
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 48; n= 278, 246	3.19 Micromoles per liter Standard Deviation 4.288	4.82 Micromoles per liter Standard Deviation 5.552
Change From Baseline in Creatinine and Bilirubin Values Bilirubin; Week 52; n= 276, 238	3.54 Micromoles per liter Standard Deviation 5.231	4.26 Micromoles per liter Standard Deviation 4.644

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Lipase Values Week 36; n= 287, 275	0.49 Unit per liter Standard Deviation 15.089	0.11 Unit per liter Standard Deviation 11.570
Change From Baseline in Lipase Values Week 4; n= 303, 301	0.17 Unit per liter Standard Deviation 11.082	1.52 Unit per liter Standard Deviation 15.067
Change From Baseline in Lipase Values Week 8; n= 299, 298	0.79 Unit per liter Standard Deviation 13.422	0.58 Unit per liter Standard Deviation 10.558
Change From Baseline in Lipase Values Week 16; n= 292, 293	2.01 Unit per liter Standard Deviation 17.174	0.94 Unit per liter Standard Deviation 11.197
Change From Baseline in Lipase Values Week 24; n= 295, 284	1.19 Unit per liter Standard Deviation 15.984	1.14 Unit per liter Standard Deviation 13.770
Change From Baseline in Lipase Values Week 48; n= 278, 247	1.13 Unit per liter Standard Deviation 14.673	1.68 Unit per liter Standard Deviation 12.783
Change From Baseline in Lipase Values Week 52; n= 275, 237	3.18 Unit per liter Standard Deviation 22.215	1.59 Unit per liter Standard Deviation 11.117

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.

Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Sodium; Grade 1	76 Participants	117 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum glucose; Grade 1	32 Participants	27 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum glucose; Grade 2	10 Participants	15 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum glucose; Grade 3	4 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum glucose; Grade 4	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALT; Grade 1	27 Participants	13 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALT; Grade 2	9 Participants	6 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALT; Grade 3	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALT; Grade 4	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Albumin; Grade 1	7 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Albumin; Grade 2	4 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Albumin; Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Albumin; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALP; Grade 1	9 Participants	22 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALP; Grade 2	4 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALP; Grade 3	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase ALP; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase AST; Grade 1	29 Participants	18 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase AST; Grade 2	10 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase AST; Grade 3	2 Participants	5 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase AST; Grade 4	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Bilirubin; Grade 1	14 Participants	21 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Bilirubin; Grade 2	3 Participants	11 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Bilirubin; Grade 3	2 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Bilirubin; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase CO2; Grade 1	99 Participants	105 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase CO2; Grade 2	24 Participants	13 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase CO2; Grade 3	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase CO2; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatine kinase; Grade 1	13 Participants	6 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatine kinase; Grade 2	2 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatine kinase; Grade 3	5 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatine kinase; Grade 4	3 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol calculation; Grade 1	17 Participants	20 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol calculation; Grade 2	4 Participants	16 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol calculation; Grade 3	1 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol calculation; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol direct; Grade 1	3 Participants	8 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol direct; Grade 2	2 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol direct; Grade 3	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase LDL cholesterol direct; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Lipase; Grade 1	16 Participants	12 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Lipase; Grade 2	6 Participants	5 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Lipase; Grade 3	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Lipase; Grade 4	2 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Phosphate; Grade 1	7 Participants	6 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Phosphate; Grade 2	15 Participants	42 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Phosphate; Grade 3	5 Participants	8 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Phosphate; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Potassium; Grade 1	16 Participants	20 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Potassium; Grade 2	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Potassium; Grade 3	2 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Potassium; Grade 4	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Sodium; Grade 2	5 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Sodium; Grade 3	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Sodium; Grade 4	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Cholesterol; Grade 1	14 Participants	46 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Cholesterol; Grade 2	5 Participants	32 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Cholesterol; Grade 3	3 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Cholesterol; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatinine; Grade 1	1 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatinine; Grade 2	2 Participants	5 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatinine; Grade 3	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Creatinine; Grade 4	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum Triglycerides; Grade 1	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum Triglycerides; Grade 2	1 Participants	11 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum Triglycerides; Grade 3	1 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase Serum Triglycerides; Grade 4	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 295

Population: Safety Continuation Population

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=274 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum glucose; Grade 1	43 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum glucose; Grade 2	33 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum glucose; Grade 3	9 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum glucose; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALT; Grade 1	46 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALT; Grade 2	16 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALT; Grade 3	2 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALT; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Albumin; Grade 1	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Albumin; Grade 2	4 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Albumin; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Albumin; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALP; Grade 1	13 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALP; Grade 2	2 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALP; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase ALP; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase AST; Grade 1	37 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase AST; Grade 2	11 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase AST; Grade 3	5 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase AST; Grade 4	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Bilirubin; Grade 1	14 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Bilirubin; Grade 2	9 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Bilirubin; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Bilirubin; Grade 4	2 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase CO2; Grade 1	83 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase CO2; Grade 2	20 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase CO2; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase CO2; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatine kinase; Grade 1	24 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatine kinase; Grade 2	6 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatine kinase; Grade 3	5 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatine kinase; Grade 4	5 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol calculation; Grade 1	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol calculation; Grade 2	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol calculation; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol calculation; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol direct; Grade 1	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol direct; Grade 2	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol direct; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase LDL cholesterol direct; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Lipase; Grade 1	19 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Lipase; Grade 2	9 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Lipase; Grade 3	2 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Lipase; Grade 4	4 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Phosphate; Grade 1	16 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Phosphate; Grade 2	38 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Phosphate; Grade 3	6 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Phosphate; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Potassium; Grade 1	24 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Potassium; Grade 2	5 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Potassium; Grade 3	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Potassium; Grade 4	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Sodium; Grade 1	69 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Sodium; Grade 2	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Sodium; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Sodium; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Cholesterol; Grade 1	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Cholesterol; Grade 2	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Cholesterol; Grade 3	1 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Cholesterol; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatinine; Grade 1	7 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatinine; Grade 2	4 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatinine; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Creatinine; Grade 4	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum Triglycerides; Grade 1	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum Triglycerides; Grade 2	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum Triglycerides; Grade 3	0 Participants	—
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase Serum Triglycerides; Grade 4	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 36; n= 283, 275	0.01 10^9 cells/liter Standard Deviation 0.151	0.02 10^9 cells/liter Standard Deviation 0.175
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 48; n= 266, 242	0.01 10^9 cells/liter Standard Deviation 0.157	0.03 10^9 cells/liter Standard Deviation 0.190
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 16; n= 287, 286	21.77 10^9 cells/liter Standard Deviation 66.974	28.03 10^9 cells/liter Standard Deviation 61.780
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 24; n= 290, 282	19.79 10^9 cells/liter Standard Deviation 63.702	27.32 10^9 cells/liter Standard Deviation 65.103
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 52; n= 265, 229	0.01 10^9 cells/liter Standard Deviation 0.173	0.02 10^9 cells/liter Standard Deviation 0.205
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 4; n= 289, 291	0.35 10^9 cells/liter Standard Deviation 1.914	0.23 10^9 cells/liter Standard Deviation 1.407
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 36; n= 283, 274	20.02 10^9 cells/liter Standard Deviation 69.570	21.41 10^9 cells/liter Standard Deviation 64.787
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 8; n= 296, 289	0.27 10^9 cells/liter Standard Deviation 1.491	0.23 10^9 cells/liter Standard Deviation 1.678
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 16; n= 286, 286	0.31 10^9 cells/liter Standard Deviation 1.462	0.29 10^9 cells/liter Standard Deviation 1.481
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 48; n= 265, 246	16.72 10^9 cells/liter Standard Deviation 66.983	30.20 10^9 cells/liter Standard Deviation 63.038
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 24; n= 290, 281	0.42 10^9 cells/liter Standard Deviation 1.694	0.34 10^9 cells/liter Standard Deviation 1.315
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 36; n= 283, 275	0.50 10^9 cells/liter Standard Deviation 1.605	0.37 10^9 cells/liter Standard Deviation 1.661
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 48; n= 266, 242	0.46 10^9 cells/liter Standard Deviation 1.491	0.50 10^9 cells/liter Standard Deviation 1.449
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophil; Week 52; n= 265, 229	0.63 10^9 cells/liter Standard Deviation 1.691	0.44 10^9 cells/liter Standard Deviation 1.604
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 4; n= 291, 293	22.81 10^9 cells/liter Standard Deviation 63.368	23.64 10^9 cells/liter Standard Deviation 53.514
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 8; n= 293, 293	22.95 10^9 cells/liter Standard Deviation 62.969	26.17 10^9 cells/liter Standard Deviation 58.634
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 4; n= 289, 291	0.00 10^9 cells/liter Standard Deviation 0.029	0.00 10^9 cells/liter Standard Deviation 0.016
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 8; n= 296, 289	0.00 10^9 cells/liter Standard Deviation 0.017	0.00 10^9 cells/liter Standard Deviation 0.017
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 16; n= 286, 286	0.00 10^9 cells/liter Standard Deviation 0.017	0.00 10^9 cells/liter Standard Deviation 0.017
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 24; n= 290, 281	0.01 10^9 cells/liter Standard Deviation 0.017	0.00 10^9 cells/liter Standard Deviation 0.017
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 36; n= 283, 275	0.01 10^9 cells/liter Standard Deviation 0.021	0.00 10^9 cells/liter Standard Deviation 0.018
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 48; n= 266, 242	0.01 10^9 cells/liter Standard Deviation 0.021	0.01 10^9 cells/liter Standard Deviation 0.019
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophil; Week 52; n= 265, 229	0.01 10^9 cells/liter Standard Deviation 0.018	0.01 10^9 cells/liter Standard Deviation 0.022
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 4; n= 290, 291	0.02 10^9 cells/liter Standard Deviation 0.182	0.02 10^9 cells/liter Standard Deviation 0.287
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 8; n= 296, 289	0.03 10^9 cells/liter Standard Deviation 0.281	0.01 10^9 cells/liter Standard Deviation 0.175
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 16; n= 286, 286	0.01 10^9 cells/liter Standard Deviation 0.240	0.01 10^9 cells/liter Standard Deviation 0.201
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 24; n= 290, 281	0.02 10^9 cells/liter Standard Deviation 0.188	0.01 10^9 cells/liter Standard Deviation 0.173
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 36; n= 283, 275	0.04 10^9 cells/liter Standard Deviation 0.214	0.02 10^9 cells/liter Standard Deviation 0.192
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 48; n= 266, 242	0.04 10^9 cells/liter Standard Deviation 0.267	0.01 10^9 cells/liter Standard Deviation 0.210
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophil; Week 52; n= 265, 229	0.02 10^9 cells/liter Standard Deviation 0.188	0.01 10^9 cells/liter Standard Deviation 0.217
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 4; n= 289, 291	0.13 10^9 cells/liter Standard Deviation 0.519	0.10 10^9 cells/liter Standard Deviation 0.549
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 8; n= 296, 289	0.23 10^9 cells/liter Standard Deviation 0.592	0.29 10^9 cells/liter Standard Deviation 0.651
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 16; n= 286, 286	0.28 10^9 cells/liter Standard Deviation 0.611	0.29 10^9 cells/liter Standard Deviation 0.668
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 24; n= 290, 281	0.31 10^9 cells/liter Standard Deviation 0.589	0.34 10^9 cells/liter Standard Deviation 0.625
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 36; n= 283, 275	0.38 10^9 cells/liter Standard Deviation 0.595	0.35 10^9 cells/liter Standard Deviation 0.646
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 48; n= 266, 242	0.38 10^9 cells/liter Standard Deviation 0.648	0.37 10^9 cells/liter Standard Deviation 0.697
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocyte; Week 52; n= 265, 229	0.34 10^9 cells/liter Standard Deviation 0.716	0.39 10^9 cells/liter Standard Deviation 0.720
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 4; n= 289, 291	0.02 10^9 cells/liter Standard Deviation 0.201	0.00 10^9 cells/liter Standard Deviation 0.167
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 8; n= 296, 289	0.01 10^9 cells/liter Standard Deviation 0.159	0.02 10^9 cells/liter Standard Deviation 0.174
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 16; n= 286, 286	-0.00 10^9 cells/liter Standard Deviation 0.140	0.01 10^9 cells/liter Standard Deviation 0.154
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocyte; Week 24; n= 290, 281	-0.01 10^9 cells/liter Standard Deviation 0.139	0.01 10^9 cells/liter Standard Deviation 0.173
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelet; Week 52; n= 267, 232	20.98 10^9 cells/liter Standard Deviation 66.402	32.60 10^9 cells/liter Standard Deviation 71.882
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 4; n= 289, 292	0.51 10^9 cells/liter Standard Deviation 2.105	0.37 10^9 cells/liter Standard Deviation 1.607
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 8; n= 296, 292	0.54 10^9 cells/liter Standard Deviation 1.676	0.54 10^9 cells/liter Standard Deviation 1.879
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 16; n= 290, 288	0.61 10^9 cells/liter Standard Deviation 1.622	0.60 10^9 cells/liter Standard Deviation 1.746
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 24; n= 291, 284	0.75 10^9 cells/liter Standard Deviation 1.826	0.70 10^9 cells/liter Standard Deviation 1.545
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 36; n= 285, 276	0.91 10^9 cells/liter Standard Deviation 1.777	0.76 10^9 cells/liter Standard Deviation 1.913
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 48; n= 267, 245	0.91 10^9 cells/liter Standard Deviation 1.777	0.90 10^9 cells/liter Standard Deviation 1.718
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocyte; Week 52; 268, 231	0.99 10^9 cells/liter Standard Deviation 1.908	0.86 10^9 cells/liter Standard Deviation 1.819

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52

Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Hematocrit Values Week 4; n= 296, 296	-0.00 Proportion of red blood cells in blood Standard Deviation 0.032	-0.01 Proportion of red blood cells in blood Standard Deviation 0.029
Change From Baseline in Hematocrit Values Week 8; n= 297, 294	0.00 Proportion of red blood cells in blood Standard Deviation 0.039	-0.01 Proportion of red blood cells in blood Standard Deviation 0.037
Change From Baseline in Hematocrit Values Week 16; n= 290, 289	0.01 Proportion of red blood cells in blood Standard Deviation 0.044	-0.01 Proportion of red blood cells in blood Standard Deviation 0.042
Change From Baseline in Hematocrit Values Week 24; n= 291, 285	0.01 Proportion of red blood cells in blood Standard Deviation 0.037	-0.00 Proportion of red blood cells in blood Standard Deviation 0.039
Change From Baseline in Hematocrit Values Week 36; n= 286, 276	0.01 Proportion of red blood cells in blood Standard Deviation 0.038	-0.00 Proportion of red blood cells in blood Standard Deviation 0.039
Change From Baseline in Hematocrit Values Week 48; n= 268, 248	0.02 Proportion of red blood cells in blood Standard Deviation 0.038	-0.00 Proportion of red blood cells in blood Standard Deviation 0.041
Change From Baseline in Hematocrit Values Week 52; n= 269, 233	0.02 Proportion of red blood cells in blood Standard Deviation 0.040	-0.00 Proportion of red blood cells in blood Standard Deviation 0.041

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52

Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Hemoglobin Values Week 4; n= 296, 296	-1.33 Gram per liter Standard Deviation 9.858	-4.23 Gram per liter Standard Deviation 8.994
Change From Baseline in Hemoglobin Values Week 8; n= 297, 294	-0.12 Gram per liter Standard Deviation 11.725	-4.41 Gram per liter Standard Deviation 11.340
Change From Baseline in Hemoglobin Values Week 16; n= 290, 289	2.39 Gram per liter Standard Deviation 12.905	-2.10 Gram per liter Standard Deviation 12.904
Change From Baseline in Hemoglobin Values Week 24; n= 291, 285	3.05 Gram per liter Standard Deviation 10.881	-0.46 Gram per liter Standard Deviation 12.363
Change From Baseline in Hemoglobin Values Week 36; n= 286, 276	5.18 Gram per liter Standard Deviation 11.968	0.34 Gram per liter Standard Deviation 12.628
Change From Baseline in Hemoglobin Values Week 48; n= 268, 248	6.05 Gram per liter Standard Deviation 12.138	0.90 Gram per liter Standard Deviation 13.486
Change From Baseline in Hemoglobin Values Week 52; n= 269, 233	5.68 Gram per liter Standard Deviation 12.457	1.07 Gram per liter Standard Deviation 13.361

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52

Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Mean Corpuscular Volume (MCV) Week 4; n= 296, 296	0.68 Femtoliter Standard Deviation 3.820	0.46 Femtoliter Standard Deviation 3.799
Change From Baseline in Mean Corpuscular Volume (MCV) Week 8; n= 297, 294	1.72 Femtoliter Standard Deviation 7.659	1.78 Femtoliter Standard Deviation 7.266
Change From Baseline in Mean Corpuscular Volume (MCV) Week 16; n= 290, 289	3.91 Femtoliter Standard Deviation 13.827	3.83 Femtoliter Standard Deviation 13.600
Change From Baseline in Mean Corpuscular Volume (MCV) Week 24; n= 291, 285	4.86 Femtoliter Standard Deviation 15.279	4.39 Femtoliter Standard Deviation 15.099
Change From Baseline in Mean Corpuscular Volume (MCV) Week 36; n= 286, 276	4.33 Femtoliter Standard Deviation 15.450	4.62 Femtoliter Standard Deviation 15.413
Change From Baseline in Mean Corpuscular Volume (MCV) Week 48; n= 268, 248	4.14 Femtoliter Standard Deviation 15.637	4.79 Femtoliter Standard Deviation 15.463
Change From Baseline in Mean Corpuscular Volume (MCV) Week 52; n= 269, 233	4.36 Femtoliter Standard Deviation 15.496	4.72 Femtoliter Standard Deviation 15.697

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52

Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Erythrocyte Values Week 4; n= 296, 296	-0.08 10^12 cells/liter Standard Deviation 0.385	-0.16 10^12 cells/liter Standard Deviation 0.363
Change From Baseline in Erythrocyte Values Week 8; n= 297, 294	-0.07 10^12 cells/liter Standard Deviation 0.558	-0.23 10^12 cells/liter Standard Deviation 0.529
Change From Baseline in Erythrocyte Values Week 16; n= 290, 289	-0.06 10^12 cells/liter Standard Deviation 0.808	-0.21 10^12 cells/liter Standard Deviation 0.754
Change From Baseline in Erythrocyte Values Week 24; n= 291, 285	-0.08 10^12 cells/liter Standard Deviation 0.768	-0.20 10^12 cells/liter Standard Deviation 0.747
Change From Baseline in Erythrocyte Values Week 36; n= 286, 276	-0.01 10^12 cells/liter Standard Deviation 0.792	-0.18 10^12 cells/liter Standard Deviation 0.749
Change From Baseline in Erythrocyte Values Week 48; n= 268, 248	0.01 10^12 cells/liter Standard Deviation 0.798	-0.18 10^12 cells/liter Standard Deviation 0.750
Change From Baseline in Erythrocyte Values Week 52; n= 269, 233	-0.01 10^12 cells/liter Standard Deviation 0.788	-0.17 10^12 cells/liter Standard Deviation 0.761

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Hematology Toxicities -Randomized Phase Hemoglobin; Grade 1	6 Participants	18 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Hemoglobin; Grade 2	5 Participants	4 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Hemoglobin; Grade 3	5 Participants	0 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Hemoglobin; Grade 4	4 Participants	1 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Leukocytes; Grade 1	19 Participants	10 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Leukocytes; Grade 2	5 Participants	5 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Leukocytes; Grade 3	3 Participants	0 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Leukocytes; Grade 4	0 Participants	0 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Neutrophils; Grade 1	25 Participants	26 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Neutrophils; Grade 2	9 Participants	11 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Neutrophils; Grade 3	10 Participants	3 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Neutrophils; Grade 4	4 Participants	0 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Platelets; Grade 1	6 Participants	4 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Platelets; Grade 2	2 Participants	7 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Platelets; Grade 3	0 Participants	1 Participants
Number of Participants With Hematology Toxicities -Randomized Phase Platelets; Grade 4	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 295

Population: Safety-Continuation Population

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=274 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Hematology Toxicities-Continuation Phase Hemoglobin; Grade 1	13 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Hemoglobin; Grade 2	2 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Hemoglobin; Grade 3	1 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Hemoglobin; Grade 4	0 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Leukocytes; Grade 1	23 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Leukocytes; Grade 2	6 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Leukocytes; Grade 3	0 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Leukocytes; Grade 4	0 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Neutrophils; Grade 1	21 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Neutrophils; Grade 2	16 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Neutrophils; Grade 3	10 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Neutrophils; Grade 4	2 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Platelets; Grade 1	6 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Platelets; Grade 2	3 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Platelets; Grade 3	1 Participants	—
Number of Participants With Hematology Toxicities-Continuation Phase Platelets; Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Number of participants who discontinued study treatment due to AEs or SAEs were summarized.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase	8 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to Week 295

Population: Safety-Continuation Population

Number of participants who discontinued study treatment due to AEs were summarized.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=274 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase	9 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 24 and Week 48

Population: Safety Population. Only those participants with data available at specified time points were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=303 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=292 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 Week 24	-0.121 Millimoles per liter Standard Error 0.0356	0.050 Millimoles per liter Standard Error 0.0378
Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 Week 48	-0.012 Millimoles per liter Standard Error 0.0387	0.135 Millimoles per liter Standard Error 0.0416

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 24 and Week 48

Population: Safety Population. Only those participants with data available at specified time point were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=306 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=295 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio Week 24	-0.237 Ratio Standard Error 0.0662	0.305 Ratio Standard Error 0.0683
Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio Week 48	-0.084 Ratio Standard Error 0.0693	0.275 Ratio Standard Error 0.0729

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol	5 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.

Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea Week 24	1 Participants	22 Participants
Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea Week 48	1 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Diarrhea Syndrome Score; Week 4; n= 303, 305	0.00 Scores on a scale Interval -0.33 to 0.0	0.00 Scores on a scale Interval 0.0 to 1.33
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Diarrhea Syndrome Score; Week 24; n= 305, 306	0.00 Scores on a scale Interval -0.33 to 0.0	0.00 Scores on a scale Interval 0.0 to 1.0
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Diarrhea Syndrome Score; Week 48; n= 305, 306	0.00 Scores on a scale Interval -0.33 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.67
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Indigestion Syndrome Score; Week 4; n=305, 306	0.00 Scores on a scale Interval -0.25 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.75
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Indigestion Syndrome Score; Week 24; n= 306, 307	0.00 Scores on a scale Interval -0.25 to 0.0	0.00 Scores on a scale Interval -0.25 to 0.5
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Indigestion Syndrome Score; Week 48; n= 306, 307	0.00 Scores on a scale Interval -0.5 to 0.0	0.00 Scores on a scale Interval -0.25 to 0.5
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Constipation Score; Week 4; n= 305, 305	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.33
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Constipation Score; Week 24; n= 306, 306	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.33
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Constipation Score; Week 48; n= 306, 306	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.33
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Abdominal pain Score; Week 4; n= 305, 306	0.00 Scores on a scale Interval -0.33 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.67
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Abdominal pain Score; Week 24; n= 306, 307	0.00 Scores on a scale Interval -0.33 to 0.0	0.00 Scores on a scale Interval -0.33 to 0.67
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Abdominal pain Score; Week 48; n= 306, 307	0.00 Scores on a scale Interval -0.67 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.33
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Reflux Score; Week 4; n= 305, 306	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.5
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Reflux Score; Week 24; n= 306, 307	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.0
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score Reflux Score; Week 48; n= 306, 307	0.00 Scores on a scale Interval 0.0 to 0.0	0.00 Scores on a scale Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score Week 4; n= 304, 306	3.4 Scores on a scale Interval 0.0 to 11.5	2.0 Scores on a scale Interval 0.0 to 10.0
Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score Week 24; n= 305, 307	5.0 Scores on a scale Interval 0.0 to 13.0	3.0 Scores on a scale Interval 0.0 to 12.0
Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score Week 48; n= 305, 307	5.0 Scores on a scale Interval 0.0 to 14.0	3.0 Scores on a scale Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48

Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.

Outcome measures

Outcome measures
Measure	Participants Receiving DTG-Randomized Phase n=312 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=312 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Baseline (Day 1, Pre-dose); low; n= 309, 312	70 Participants	75 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Baseline (Day 1, Pre-dose); medium; n= 309, 312	102 Participants	100 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Baseline (Day 1, Pre-dose); high; n= 309, 312	137 Participants	137 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 4; low; n= 306, 306	17 Participants	37 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 4; medium; n= 306, 306	81 Participants	80 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 4; high n= 306, 306	208 Participants	189 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 24; low; n= 307, 307	25 Participants	39 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 24; medium; n= 307, 307	83 Participants	76 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 24; high; n= 307,307	199 Participants	192 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 48; low; n= 307, 307	28 Participants	52 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 48; medium; n= 307, 307	74 Participants	82 Participants
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) Week 48; high; n= 307, 307	205 Participants	173 Participants

Adverse Events

Participants Receiving DTG-Randomized Phase

Serious events: 20 serious events

Other events: 155 other events

Deaths: 2 deaths

Participants Receiving LPV/RTV-Randomized Phase

Serious events: 20 serious events

Other events: 202 other events

Deaths: 3 deaths

Participants Receiving DTG-Continuation Phase

Serious events: 29 serious events

Other events: 150 other events

Deaths: 3 deaths

DTG in Randomized Phase Followed by Continuation Phase

Serious events: 47 serious events

Other events: 218 other events

Deaths: 5 deaths

LPV/RTV-Randomized Phase Followed by DTG in Continuation Phase

Serious events: 20 serious events

Other events: 213 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Participants Receiving DTG-Randomized Phase n=314 participants at risk Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 participants at risk Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.	Participants Receiving DTG-Continuation Phase n=274 participants at risk Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.	DTG in Randomized Phase Followed by Continuation Phase n=314 participants at risk Participants received 1 tablet of 50 mg of DTG once daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants who completed 52 weeks of treatment, continued to receive DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.	LPV/RTV-Randomized Phase Followed by DTG in Continuation Phase n=310 participants at risk Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants switched to DTG by Week 52 continued to receive DTG in Continuation Phase until it was either locally approved and commercial supplies were available.
Infections and infestations Pneumonia	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Cerebral toxoplasmosis	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Bone tuberculosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Cholecystitis infective	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Encephalitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Epstein-Barr virus infection	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Extrapulmonary tuberculosis	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Gastroenteritis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Immune reconstitution inflammatory syndrome associated tuberculosis	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Influenza	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Lower respiratory tract infection	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Blood and lymphatic system disorders Anaemia	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Anal fistula	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Enteritis	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Inguinal hernia	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebellopontine angle tumour	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Nervous system disorders Headache	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Nervous system disorders Seizure	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Cardiac disorders Pericardial effusion	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Cardiac disorders Sinus bradycardia	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Hepatobiliary disorders Drug-induced liver injury	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.64% 2/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Exposure to toxic agent	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Metabolism and nutrition disorders Hypokalaemia	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.64% 2/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.1% 3/274 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/314 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Psychiatric disorders Depression	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Psychiatric disorders Suicidal ideation	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Renal and urinary disorders Nephrolithiasis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Skin and subcutaneous tissue disorders Rash	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Vascular disorders Deep vein thrombosis	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Appendicitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations COVID-19	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Helicobacter gastritis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Herpes zoster	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Intestinal tuberculosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Leptospirosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Meningitis bacterial	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Meningitis viral	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Pyelonephritis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Secondary syphilis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Tuberculosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Tuberculosis gastrointestinal	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile cancer	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Intestinal perforation	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.1% 3/274 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Renal and urinary disorders Calculus urinary	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Renal and urinary disorders Hydronephrosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Vascular disorders Orthostatic hypotension	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
General disorders Death	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.36% 1/274 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/314 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.

Other adverse events

Other adverse events
Measure	Participants Receiving DTG-Randomized Phase n=314 participants at risk Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 participants at risk Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.	Participants Receiving DTG-Continuation Phase n=274 participants at risk Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.	DTG in Randomized Phase Followed by Continuation Phase n=314 participants at risk Participants received 1 tablet of 50 mg of DTG once daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants who completed 52 weeks of treatment, continued to receive DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.	LPV/RTV-Randomized Phase Followed by DTG in Continuation Phase n=310 participants at risk Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants switched to DTG by Week 52 continued to receive DTG in Continuation Phase until it was either locally approved and commercial supplies were available.
Gastrointestinal disorders Diarrhoea	8.9% 28/314 • Number of events 35 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	33.9% 105/310 • Number of events 134 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.9% 19/274 • Number of events 25 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	12.1% 38/314 • Number of events 54 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	33.9% 105/310 • Number of events 134 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Nausea	3.2% 10/314 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	9.7% 30/310 • Number of events 33 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.8% 5/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.5% 14/314 • Number of events 16 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	9.7% 30/310 • Number of events 33 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Vomiting	1.6% 5/314 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.8% 21/310 • Number of events 24 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.73% 2/274 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.8% 21/310 • Number of events 24 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Dyspepsia	3.2% 10/314 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.9% 12/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.3% 9/274 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.1% 19/314 • Number of events 22 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.9% 12/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Abdominal pain	2.9% 9/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 7/274 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.1% 16/314 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Flatulence	1.9% 6/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Upper respiratory tract infection	14.3% 45/314 • Number of events 59 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	13.9% 43/310 • Number of events 52 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	23.7% 65/274 • Number of events 122 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	26.4% 83/314 • Number of events 178 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	13.9% 43/310 • Number of events 52 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Lower respiratory tract infection	4.1% 13/314 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.5% 14/310 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.8% 16/274 • Number of events 28 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	7.0% 22/314 • Number of events 48 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.5% 14/310 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Nasopharyngitis	2.5% 8/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.9% 12/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.6% 10/274 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.4% 17/314 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.9% 12/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Influenza	2.2% 7/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 9/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.4% 12/274 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.7% 18/314 • Number of events 22 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 9/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Herpes zoster	1.6% 5/314 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Syphilis	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.8% 12/314 • Number of events 12 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Urinary tract infection	2.9% 9/314 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.4% 12/274 • Number of events 15 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.7% 18/314 • Number of events 25 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Nervous system disorders Headache	7.6% 24/314 • Number of events 24 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.2% 16/310 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.7% 13/274 • Number of events 15 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	11.8% 37/314 • Number of events 39 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.2% 16/310 • Number of events 17 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Nervous system disorders Dizziness	2.9% 9/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 9/314 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Skin and subcutaneous tissue disorders Rash	3.5% 11/314 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.4% 17/314 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Skin and subcutaneous tissue disorders Pruritus	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 8/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
General disorders Fatigue	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
General disorders Pyrexia	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.5% 11/314 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 14/314 • Number of events 16 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	5.8% 16/274 • Number of events 18 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	8.6% 27/314 • Number of events 34 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/310 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Blood and lymphatic system disorders Anaemia	2.9% 9/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.2% 13/310 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/314 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.2% 13/310 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Psychiatric disorders Insomnia	2.5% 8/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 7/274 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.5% 14/314 • Number of events 15 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Abdominal discomfort	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.64% 2/314 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Gastroenteritis	0.96% 3/314 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 8/274 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/314 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Metabolism and nutrition disorders Decreased appetite	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 8/274 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.5% 14/314 • Number of events 16 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 6/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.4% 12/274 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.4% 20/314 • Number of events 25 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Gastritis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.5% 4/274 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.3% 4/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Haemorrhoids	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.97% 3/310 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.97% 3/310 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Gastrointestinal disorders Constipation	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 9/314 • Number of events 10 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Respiratory tract infection viral	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Bronchitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.6% 5/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Conjunctivitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 8/274 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.9% 9/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.3% 4/310 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Sinusitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.8% 5/274 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Acarodermatitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.97% 3/310 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Pneumonia	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.3% 4/310 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Infections and infestations Tonsillitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.32% 1/310 • Number of events 1 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	6.9% 19/274 • Number of events 20 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	7.6% 24/314 • Number of events 27 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.3% 7/310 • Number of events 7 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.6% 7/274 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.8% 12/314 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.3% 4/310 • Number of events 4 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/314 • Number of events 11 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.97% 3/310 • Number of events 3 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.5% 8/314 • Number of events 9 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Investigations Alanine aminotransferase increased	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.6% 10/274 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.5% 11/314 • Number of events 15 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Investigations Weight decreased	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.8% 5/274 • Number of events 5 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 7/314 • Number of events 8 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Investigations Blood pressure increased	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/274 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.2% 10/314 • Number of events 13 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.65% 2/310 • Number of events 2 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Vascular disorders Hypertension	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	3.6% 10/274 • Number of events 14 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	4.8% 15/314 • Number of events 19 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	1.9% 6/310 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	2.2% 6/274 • Number of events 6 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/314 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.	0.00% 0/310 • All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase. All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Participants Receiving DTG-Randomized Phase n=314 Participants Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.	Participants Receiving LPV/RTV-Randomized Phase n=310 Participants Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 4; n= 306, 302	-12.24 International unit per liter Standard Deviation 21.900	-14.94 International unit per liter Standard Deviation 22.979
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 8; n= 301, 298	-13.73 International unit per liter Standard Deviation 26.135	-13.46 International unit per liter Standard Deviation 29.998
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 16; n= 294, 292	-13.87 International unit per liter Standard Deviation 31.452	-11.38 International unit per liter Standard Deviation 26.190
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 24; n= 295, 286	-14.19 International unit per liter Standard Deviation 27.800	-6.06 International unit per liter Standard Deviation 50.943
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 36; n= 289, 276	-13.53 International unit per liter Standard Deviation 28.875	-7.85 International unit per liter Standard Deviation 30.394
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 48; n= 278, 247	-14.10 International unit per liter Standard Deviation 28.935	-6.87 International unit per liter Standard Deviation 32.071
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALP; Week 52; n= 276, 238	-13.81 International unit per liter Standard Deviation 29.317	-7.23 International unit per liter Standard Deviation 31.046
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 4; n= 306, 302	-2.50 International unit per liter Standard Deviation 17.285	-10.25 International unit per liter Standard Deviation 17.639
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 8; n= 301, 298	-2.49 International unit per liter Standard Deviation 19.222	-9.04 International unit per liter Standard Deviation 25.556
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 16; n= 294, 292	-4.32 International unit per liter Standard Deviation 18.502	-8.59 International unit per liter Standard Deviation 24.507
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 24; n= 295, 286	-3.87 International unit per liter Standard Deviation 20.108	-9.20 International unit per liter Standard Deviation 33.054
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 36; n= 289, 276	-1.31 International unit per liter Standard Deviation 25.356	-11.16 International unit per liter Standard Deviation 22.196
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 48; n= 278, 247	0.19 International unit per liter Standard Deviation 39.985	-6.47 International unit per liter Standard Deviation 51.492
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values ALT; Week 52; n= 276, 238	-1.04 International unit per liter Standard Deviation 23.232	-10.63 International unit per liter Standard Deviation 25.508
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 4; n= 306, 302	-3.56 International unit per liter Standard Deviation 17.463	-7.68 International unit per liter Standard Deviation 13.654
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 8; n= 301, 297	-2.89 International unit per liter Standard Deviation 17.934	-6.64 International unit per liter Standard Deviation 21.295
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 16; n= 294, 292	-4.70 International unit per liter Standard Deviation 17.445	-6.49 International unit per liter Standard Deviation 18.143
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 24; n= 295, 286	-3.83 International unit per liter Standard Deviation 17.713	-6.45 International unit per liter Standard Deviation 28.933
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 36; n= 289, 276	-1.76 International unit per liter Standard Deviation 22.437	-8.36 International unit per liter Standard Deviation 21.550
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 48; n= 278, 247	-2.03 International unit per liter Standard Deviation 28.194	-6.43 International unit per liter Standard Deviation 27.155
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values AST; Week 52; n= 276, 238	-1.51 International unit per liter Standard Deviation 22.645	-7.55 International unit per liter Standard Deviation 28.125
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 4; n= 306, 302	-2.85 International unit per liter Standard Deviation 215.820	-15.59 International unit per liter Standard Deviation 106.738
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 8; n= 301, 298	18.61 International unit per liter Standard Deviation 312.940	-10.42 International unit per liter Standard Deviation 128.109
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 16; n= 294, 292	11.75 International unit per liter Standard Deviation 180.905	11.62 International unit per liter Standard Deviation 203.660
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 24; n= 295, 286	34.71 International unit per liter Standard Deviation 312.173	-0.28 International unit per liter Standard Deviation 186.927
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 36; n= 289, 276	72.34 International unit per liter Standard Deviation 892.830	-5.08 International unit per liter Standard Deviation 135.191
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 48; n= 278, 247	45.50 International unit per liter Standard Deviation 451.135	16.52 International unit per liter Standard Deviation 295.891
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values Creatine kinase; Week 52; n= 276, 238	39.24 International unit per liter Standard Deviation 228.026	54.97 International unit per liter Standard Deviation 628.621